The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Revision Hip Prosthesis, Femoral Component.
| Device ID | K853524 |
| 510k Number | K853524 |
| Device Name: | APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Composite/metal |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | KMC |
| CFR Regulation Number | 888.3340 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-22 |
| Decision Date | 1985-11-22 |