Osteogenics Biomedical, Inc.
Lubbock, TX, US
OSTEOGENICS BIOMEDICAL, INC. appears in FDA device records in Lubbock, TX. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Osteogenics Biomedical, Inc. between 1999 and 2021. The busiest year on record is 2000, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | NPK | Substantially Equivalent | |
| K171774 | RPM Reinforced PTFE Mesh | NPK | Substantially Equivalent | |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | DZL | Substantially Equivalent | |
| K072076 | CYTOPLAST PTFE SUTURE | NBY | Substantially Equivalent | |
| K013764 | IMMIX BONE GRAFT EXTENDER | KKY | Substantially Equivalent | |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | NBY | Substantially Equivalent | |
| K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 | LYC | Substantially Equivalent | |
| K984230 | OSTEO-MESH TM-300 | JEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1650372 | 3002253367 | OSTEOGENICS BIOMEDICAL, INC. | 4620 71st St Bldg 78-79, LUBBOCK, TX 79424 US | 2026 | and 1 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
- EJBHandle, Instrument, Dental
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- JEYPlate, Bone
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- LRPTray, Surgical
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0113-2017 | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects. | The device has the potential to be packaged in the wrong product box. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain