Company ยท US
Osteogenics Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2021. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes Osteogenics Biomedical, Inc. | NPK |
| Oct 19, 2017 | K171774 | RPM Reinforced PTFE Mesh Osteogenics Biomedical, Inc. | NPK |
| Mar 1, 2010 | K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# Osteogenics Biomedical, Inc. | DZL |
| Oct 31, 2007 | K072076 | CYTOPLAST PTFE SUTURE Osteogenics Biomedical, Inc. | NBY |
| May 16, 2002 | K013764 | IMMIX BONE GRAFT EXTENDER Osteogenics Biomedical, Inc. | KKY |
| Nov 24, 2000 | K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC Osteogenics Biomedical, Inc. | NBY |
| Mar 2, 2000 | K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 Osteogenics Biomedical, Inc. | LYC |
| Feb 4, 1999 | K984230 | OSTEO-MESH TM-300 Osteogenics Biomedical, Inc. | JEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2016 | Osteogenics Biomedical, Inc. 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. Terminated |
LYC | K972278 |