Integra LifeSciences Braintree Inc.
Braintree, MA, US
Integra LifeSciences Braintree Inc. appears in FDA device records in Braintree, MA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 18 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Integra LifeSciences Braintree Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Tei Biosciences, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Integra LifeSciences Braintree Inc. between 2002 and 2017. The busiest year on record is 2006, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | FTM | Substantially Equivalent | |
| K153690 | PriMatrix Dermal Repair Scaffold | KGN | Substantially Equivalent | |
| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | Substantially Equivalent | |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | FRO | Substantially Equivalent | |
| K083898 | SURGIMEND | FTM | Substantially Equivalent | |
| K083440 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | Substantially Equivalent | |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | FTM | Substantially Equivalent | |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | KGN | Substantially Equivalent | |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent | |
| K060829 | COSMATRIX | FTM | Substantially Equivalent | |
| K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent | |
| K051766 | ORTHOMEND | FTL | Substantially Equivalent | |
| K051190 | XENFORM SOFT TISSUE REPAIR MATRIX | PAJ | Substantially Equivalent | |
| K023778 | DRESSSKIN | KGN | Substantially Equivalent | |
| K031188 | ORTHOMEND | FTL | Substantially Equivalent | |
| K020455 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004170064 | 3004170064 | Integra LifeSciences Braintree Inc. | 400b Wood Rd, Braintree, MA 02184 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FRODressing, Wound, Drug
- GXQDura Substitute
- FTMMesh, Surgical
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- FTLMesh, Surgical, Polymeric
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2085-2023 | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2084-2023 | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2083-2023 | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2082-2023 | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1). | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2081-2023 | PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2080-2023 | PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2079-2023 | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1). | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2078-2023 | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1). | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2077-2023 | PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2076-2023 | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2075-2023 | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2074-2023 | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2073-2023 | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2072-2023 | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval, | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2071-2023 | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2070-2023 | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-2069-2023 | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Class II | Open, Classified | |
| Z-0383-2018 | PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain