Osteo AG: FDA clearances and approvals
Osteo AG has 9 FDA 510(k) clearances (first 1991, latest 1994), across 6 product codes in 2 review panels. Median 510(k) review time: 73 days.
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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
Review panels
- Orthopedic (8)
- Ophthalmic (1)
Most recent Osteo AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933340 | OSTEO INTERLOCKING-COMPRESSION NAIL | HSB | 1994-06-30 | 357 |
| K922196 | OSTEO TIBIA NAIL | HSB | 1992-07-23 | 73 |
| K922195 | OSTEO FEMORAL NAIL | HSB | 1992-07-23 | 73 |
| K922194 | OSTEO STEINMANN PIN | HTY | 1992-07-23 | 73 |
| K922193 | OSTEO KIRSCHNER WIRE | HTY | 1992-07-23 | 73 |
| K920149 | OSTEO EX-FI-RE | JEC | 1992-04-09 | 90 |
| K920037 | OSTEO COMPRESSION HIP SCREW | HRC | 1992-03-11 | 65 |
| K914374 | OSTEO CERCLAGE WIRE | JDQ | 1991-12-30 | 90 |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | HSZ | 1991-11-07 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Osteo AG.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Osteo AG have?
Osteo AG has 9 FDA 510(k) clearances (first 1991, latest 1994), across 6 product codes in 2 review panels.
How long does FDA take to clear Osteo AG's 510(k)s?
The median time from FDA receipt to decision across Osteo AG's cleared 510(k)s is 73 days.
What devices does Osteo AG make?
Its most frequent FDA product codes are HSB (Rod, Fixation, Intramedullary And Accessories, 3); HTY (Pin, Fixation, Smooth, 2); HRC (Sterilizer, Soft-Lens, Thermal, Battery-Powered, 1).
Has Osteo AG had device recalls?
openFDA lists no recalls under a recalling firm name matching Osteo AG. Related entities may recall under other names.
Next steps
- See all 9 Osteo AG clearances with predicates and recalls
- Run predicate analysis for product code HSB, Osteo AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.