Osteogenics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Osteogenics, Inc.” (first 1996, latest 2007), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 238 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 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| GXP | Methyl Methacrylate For Cranioplasty | 2 | 2 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
Review panels
- Dental (2)
- Neurology (2)
- General and Plastic Surgery (2)
Most recent Osteogenics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061934 | XTAC | FTL | 2007-07-17 | 375 |
| K983753 | STAR TEMPORARY WOUND COVER | FTL | 1999-11-18 | 398 |
| K972278 | CYTOPLAST REGENTEX TITANIUM 250 | LYC | 1997-08-06 | 49 |
| K964342 | CYTOPLAST GBR | LYC | 1997-03-11 | 131 |
| K964537 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | GXP | 1997-01-24 | 73 |
| K953339 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | GXP | 1996-06-27 | 346 |
Recalls
openFDA lists no recalls under a recalling firm named Osteogenics, Inc..
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 Biomedical, Inc. (8 510(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, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Osteogenics, Inc.” (first 1996, latest 2007), across 3 product codes in 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteogenics, Inc. is 238 days.
Which FDA product codes appear under Osteogenics, Inc.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 2); GXP (Methyl Methacrylate For Cranioplasty, 2); LYC (Bone Grafting Material, Synthetic, 2).
Next steps
- See all 6 Osteogenics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Osteogenics, 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.