Data / Medical devices / United States / Osteogenics Biomedical, Inc.
Osteogenics Biomedical, Inc.: FDA-registered device maker in Lubbock, TX, United States, 13 510(k) clearances
Osteogenics Biomedical, Inc. is registered with the FDA (registration 1650372) in Lubbock, TX, United States. It lists 11 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 2, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1650372
- FEI number
- 3002253367
- Address
- 4620 71st St Bldg 78-79, Lubbock, TX, United States, 79424
- Owner or operator
- OSTEOGENICS BIOMEDICAL, INC. (9028315)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- Cytoplast GBR/TXT d-PTFE Membranes, Cytoplast PTFE Sutures, Cytoplast RTM Collagen Membrane, Cytoplast Titanium-Reinforced PTFE Membranes, Osteo-Mesh TM-300 Titanium Mesh, Pro-Fix Contra Angle Driver Blade, Pro-fix 56 mm Cruciform Driver Blade, Pro-fix 76 mm Cruciform Driver Blade and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Barrier, Synthetic, Intraoral | NPK | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2021 | K202183 | Porcine Mineral Collagen Composite | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| January 23, 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | NPK | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| September 11, 2020 | K201859 | Porcine Mineral Collagen Composite Moldable | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 19, 2017 | K171774 | RPM Reinforced PTFE Mesh | NPK | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| February 9, 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| June 23, 2016 | K152600 | Collagen Dental Wound Dressings | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 16, 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 1, 2010 | K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | DZL | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| October 31, 2007 | K072076 | CYTOPLAST PTFE SUTURE | NBY | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| August 7, 2001 | K011695 | COLLAGEN DENTAL MEMBRANE | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| February 4, 1999 | K984230 | OSTEO-MESH TM-300 | JEY | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| August 6, 1997 | K972278 | CYTOPLAST REGENTEX TITANIUM 250 | LYC | Substantially Equivalent | Osteogenics Co. | accessdata.fda.gov |
| March 11, 1997 | K964342 | CYTOPLAST GBR | LYC | Substantially Equivalent | Osteogenics Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 7, 2016 | 75119 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier, Synthetic, Intraoral
- All makers of Plate, Bone
- All makers of Tray, Surgical
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- All makers of Barrier, Animal Source, Intraoral
- All makers of Handle, Instrument, Dental
Updated April 2, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.