Orthopaedic Innovations, Inc.
Golden Valley, MN, US
Orthopaedic Innovations, Inc. appears in FDA device records in Golden Valley, MN. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Orthopaedic Innovations, Inc. between 1995 and 2002. The busiest year on record is 1996, with 4. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 4 |
| 1998 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020145 | ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | |
| K983881 | COBRA EXTERNAL FIXATOR | HRS | Substantially Equivalent | |
| K962646 | PRIME MODULAR ENDO HEAD | KWL | Substantially Equivalent | |
| K960014 | PRACTIFIX EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS | JDI | Substantially Equivalent | |
| K955751 | PRIME FEMORAL CEMENT PLUG | LZN | Substantially Equivalent | |
| K953033 | PRIME CEMENTED SMALL FEMORAL STEM | JDI | Substantially Equivalent | |
| K940328 | PRIME CEMENTED HIP SYSTEM | JDI | Substantially Equivalent for Some Indications |
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