Osteo AG
Greenwood, SC, US
Osteo AG appears in FDA device records in Greenwood, SC. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Osteo AG between 1991 and 1994. The busiest year on record is 1992, with 6. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1992 | 6 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933340 | OSTEO INTERLOCKING-COMPRESSION NAIL | HSB | Substantially Equivalent | |
| K922196 | OSTEO TIBIA NAIL | HSB | Substantially Equivalent | |
| K922195 | OSTEO FEMORAL NAIL | HSB | Substantially Equivalent | |
| K922194 | OSTEO STEINMANN PIN | HTY | Substantially Equivalent | |
| K922193 | OSTEO KIRSCHNER WIRE | HTY | Substantially Equivalent | |
| K920149 | OSTEO EX-FI-RE | JEC | Substantially Equivalent | |
| K920037 | OSTEO COMPRESSION HIP SCREW | HRC | Substantially Equivalent | |
| K914374 | OSTEO CERCLAGE WIRE | JDQ | Substantially Equivalent | |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | HSZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain