Osteomedics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Osteomedics, Inc.” (first 2001, latest 2003), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 6 | 6 |
| JEY | Plate, Bone | 4 | 4 |
Review panels
- Orthopedic (6)
- Dental (4)
Most recent Osteomedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022035 | OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB | JEY | 2003-01-17 | 210 |
| K022324 | NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM | HRS | 2002-09-17 | 62 |
| K022231 | NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM | HRS | 2002-09-13 | 65 |
| K022230 | NORMED MINI EXTERNAL FIXATOR SYSTEM | HRS | 2002-09-10 | 62 |
| K022325 | NORMED TITANIUM OSTEOTOMY PLATING SYSTEM | HRS | 2002-09-09 | 54 |
| K022323 | NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM | HRS | 2002-09-09 | 54 |
| K021342 | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | JEY | 2002-08-01 | 94 |
| K021341 | NORMED BONE TRANSPORT DISTRACTION DEVICE | JEY | 2002-08-01 | 94 |
| K010118 | NORMED MANDIBULAR FIXATION SYSTEM | JEY | 2001-08-14 | 210 |
| K011118 | NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM | HRS | 2001-07-20 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Osteomedics, 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 Osteomedics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Osteomedics, Inc.” (first 2001, latest 2003), across 2 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 Osteomedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteomedics, Inc. is 80 days.
Which FDA product codes appear under Osteomedics, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 6); JEY (Plate, Bone, 4).
Next steps
- See all 10 Osteomedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Osteomedics, 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.