The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Hip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented Prosthesis.
| Device ID | K953510 |
| 510k Number | K953510 |
| Device Name: | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1995-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912077507 | K953510 | 000 |
| 00888912077347 | K953510 | 000 |
| 00888912023436 | K953510 | 000 |
| 00888912077323 | K953510 | 000 |
| 00888912077330 | K953510 | 000 |
| 00888912077279 | K953510 | 000 |
| 00888912077262 | K953510 | 000 |
| 00888912077248 | K953510 | 000 |
| 00888912077231 | K953510 | 000 |
| 00888912077217 | K953510 | 000 |
| 00888912077194 | K953510 | 000 |
| 00888912077163 | K953510 | 000 |
| 00888912077132 | K953510 | 000 |
| 00888912077118 | K953510 | 000 |
| 00888912077354 | K953510 | 000 |
| 00888912077361 | K953510 | 000 |
| 00888912077491 | K953510 | 000 |
| 00888912077484 | K953510 | 000 |
| 00888912077477 | K953510 | 000 |
| 00888912077460 | K953510 | 000 |
| 00888912077453 | K953510 | 000 |
| 00888912077446 | K953510 | 000 |
| 00888912077439 | K953510 | 000 |
| 00888912077422 | K953510 | 000 |
| 00888912077415 | K953510 | 000 |
| 00888912077408 | K953510 | 000 |
| 00888912077392 | K953510 | 000 |
| 00888912077385 | K953510 | 000 |
| 00888912077378 | K953510 | 000 |
| 00888912077255 | K953510 | 000 |