Osteobiologics, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Osteobiologics, Inc.” (first 2002, latest 2005), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 126 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | 1 | 1 |
Review panels
Most recent Osteobiologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051656 | OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM | HRX | 2005-10-25 | 126 |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | JDK | 2005-06-17 | 388 |
| K043172 | TRUGRAFT BGS SYRINGE, MODEL 600-041 | FMF | 2005-01-07 | 52 |
| K040047 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | MQV | 2004-12-17 | 340 |
| K033707 | POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX | MQV | 2004-08-16 | 264 |
| K032673 | IMMIX PLASTIFILM | FTL | 2003-10-02 | 34 |
| K030288 | POLYGRAFT BONE GRAFT SUBSTITUTE | MQV | 2003-07-17 | 170 |
| K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP | FTL | 2003-03-14 | 84 |
| K013429 | ACTAEON PROBE | NGR | 2002-01-11 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Osteobiologics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Osteobiologics, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Osteobiologics, Inc.” (first 2002, latest 2005), across 6 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 Osteobiologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteobiologics, Inc. is 126 days.
Which FDA product codes appear under Osteobiologics, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 3); FTL (Mesh, Surgical, Polymeric, 2); FMF (Syringe, Piston, 1).
Next steps
- See all 9 Osteobiologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Osteobiologics, 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.