Osteogenics Biomedical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Osteogenics Biomedical, Inc.” (first 1999, latest 2021), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 127 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 267 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osteogenics Biomedical, Inc. took a median 197 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 228 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
Most recent Osteogenics Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | NPK | 2021-01-23 | 267 |
| K171774 | RPM Reinforced PTFE Mesh | NPK | 2017-10-19 | 127 |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | DZL | 2010-03-01 | 89 |
| K072076 | CYTOPLAST PTFE SUTURE | NBY | 2007-10-31 | 93 |
| K013764 | IMMIX BONE GRAFT EXTENDER | KKY | 2002-05-16 | 184 |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | NBY | 2000-11-24 | 57 |
| K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 | LYC | 2000-03-02 | 129 |
| K984230 | OSTEO-MESH TM-300 | JEY | 1999-02-04 | 71 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-09-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Osteogenics, Inc. (6 510(k)s)
- Osteogenics Biomedical, Inc. (Formerly Obi Biologi (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osteogenics Biomedical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Osteogenics Biomedical, Inc.” (first 1999, latest 2021), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Osteogenics Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteogenics Biomedical, Inc. is 110 days.
Which FDA product codes appear under Osteogenics Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, 2); NPK (Barrier, Synthetic, Intraoral, 2); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 8 Osteogenics Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBY, Osteogenics Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.