Collagen Matrix, Inc
Oakland, NJ, US
COLLAGEN MATRIX, INC. appears in FDA device records in Oakland, NJ. FDA records list 47 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 47 510(k) clearances for Collagen Matrix, Inc between 2001 and 2025. The busiest year on record is 2004, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 4 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | GXQ | Substantially Equivalent | |
| K243071 | Bovine Dermis Collagen Dermal Matrix | KGN | Substantially Equivalent | |
| K242302 | RejuvaKnee™ Collagen Meniscus Implant | OLC | Substantially Equivalent | |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | NPL | Substantially Equivalent | |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | MQV | Substantially Equivalent | |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | MQV | Substantially Equivalent | |
| K221735 | Mineral Collagen Composite Bioactive Moldable | MQV | Substantially Equivalent | |
| K213341 | Fibrillar Collagen Wound Dressing | KGN | Substantially Equivalent | |
| K202183 | Porcine Mineral Collagen Composite | NPM | Substantially Equivalent | |
| K201859 | Porcine Mineral Collagen Composite Moldable | NPM | Substantially Equivalent | |
| K182074 | Mineral Collagen Composite Bioactive Moldable | MQV | Substantially Equivalent | |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | NPM | Substantially Equivalent | |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | JXI | Substantially Equivalent | |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | |
| K152600 | Collagen Dental Wound Dressings | KGN | Substantially Equivalent | |
| K150825 | Collagen Dural Regeneration Matrix | GXQ | Substantially Equivalent | |
| K141608 | COLLAGEN DURA MEMBRANE | GXQ | Substantially Equivalent | |
| K142496 | Collagen Dental Membrane - Conformable IIBP | NPL | Substantially Equivalent | |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | NPL | Substantially Equivalent | |
| K140714 | PORCINE ANORGANIC BONE MINERAL | NPM | Substantially Equivalent | |
| K131541 | FLEXIBLE COOAGEN NERVE CUFF | JXI | Substantially Equivalent | |
| K122115 | COLLAGEN DENTAL WOUND DRESSINGS | KGN | Substantially Equivalent | |
| K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | NPL | Substantially Equivalent | |
| K100156 | COLLAGEN DENTAL MEMBRANE V | NPL | Substantially Equivalent | |
| K092608 | SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | MQV | Substantially Equivalent | |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | NPL | Substantially Equivalent | |
| K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC | Substantially Equivalent | |
| K080452 | COLLAGEN TENDON WRAP | FTM | Substantially Equivalent | |
| K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | LYC | Substantially Equivalent | |
| K062200 | COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS | MQV | Substantially Equivalent | |
| K062846 | COLLAGEN DENTAL MEMBRANE III | NPL | Substantially Equivalent | |
| K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | NPL | Substantially Equivalent | |
| K060952 | COLLAGEN NERVE WRAP | JXI | Substantially Equivalent | |
| K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE | GXQ | Substantially Equivalent | |
| K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL | MQV | Substantially Equivalent | |
| K052041 | COLLAGEN BONE HEALING PROTECTIVE SHEET | HRS | Substantially Equivalent | |
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | NPM | Substantially Equivalent | |
| K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE | GXQ | Substantially Equivalent | |
| K040403 | COLLAGEN WOUND DRESSING - ORAL | KGN | Substantially Equivalent | |
| K040558 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | |
| K033729 | COLLAGEN DENTAL WOUND DRESSINGS | LYC | Substantially Equivalent | |
| K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | |
| K030921 | COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | |
| K012814 | COLLAGEN NERVE CUFF | JXI | Substantially Equivalent | |
| K011695 | COLLAGEN DENTAL MEMBRANE | NPL | Substantially Equivalent | |
| K003339 | COLLAGEN PERIODONTAL MEMBRANE | NPL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2249852 | 3008817245 | COLLAGEN MATRIX, INC. | 15 Thornton Rd, Oakland, NJ 07436 US | 2026 | and 3 more, listed in full below |
| 3003300673 | 3003300673 | Collagen Matrix, Inc | 110 Commerce Dr, Allendale, NJ 07401 US | 2026 | |
| 3027448274 | 3027448274 | Collagen Matrix, Inc. | 10 Industrial Ave, Mahwah, NJ 07430 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NPLBarrier, Animal Source, Intraoral
- NPKBarrier, Synthetic, Intraoral
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- JXICuff, Nerve
- GXQDura Substitute
- MQVFiller, Bone Void, Calcium Compound
- FTMMesh, Surgical
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- ORQMesh, Surgical, Deployer
- HRSPlate, Fixation, Bone
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- EIDSyringe, Restorative And Impression Material
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1777-2022 | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm | The packaging may not be sealed, which could compromise sterility. | Class II | Open, Classified | |
| Z-0669-2022 | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125 | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery | Class II | Terminated | |
| Z-0668-2022 | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery | Class II | Terminated | |
| Z-0912-2020 | GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-0911-2020 | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-0910-2020 | GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-0909-2020 | GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-0908-2020 | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-0907-2020 | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | The products may have been packaged with an incorrect Instructions for Use. | Class II | Terminated | |
| Z-1389-2019 | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue. | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box | Class II | Terminated | |
| Z-0752-2019 | Porcine Anorganic Bone Mineral 4.0cc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. | Class III | Terminated | |
| Z-0414-2019 | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct. | Class III | Terminated | |
| Z-1173-2016 | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration. | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. | Class III | Terminated | |
| Z-1096-2016 | NuOSS Cancellous Intended for use in dental surgery. | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. | Class II | Terminated | |
| Z-1097-2016 | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain