APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
FDA 510(k) clearance K853524 · decided 1985-11-22
Clearance details
- K-number
- K853524
- Device name
- APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
- Applicant
- Intermedics Orthopedics
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1985-08-22
- Decision date
- 1985-11-22
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- KMC
- Device class
- 2
- Regulation number
- 888.3340
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENHANCED MODULAR AUSTIN MOORE HIP (K936044) | Zimmer, Inc. | 1994-04-26 |
| MALLORY/HEAD TOTAL HIP SYSTEM (K853259) | Biomet, Inc. | 1985-11-01 |
Recalls involving this device
No recalls on record reference this clearance.