The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Porous Hip Stem.
| Device ID | K991226 |
| 510k Number | K991226 |
| Device Name: | FOUNDATION POROUS HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912086479 | K991226 | 000 |
| 00888912086233 | K991226 | 000 |
| 00888912086264 | K991226 | 000 |
| 00888912086288 | K991226 | 000 |
| 00888912086318 | K991226 | 000 |
| 00888912086325 | K991226 | 000 |
| 00888912086455 | K991226 | 000 |
| 00888912086462 | K991226 | 000 |
| 00888912086486 | K991226 | 000 |
| 00888912086493 | K991226 | 000 |
| 00888912086509 | K991226 | 000 |
| 00888912086523 | K991226 | 000 |
| 00888912086530 | K991226 | 000 |
| 00888912086240 | K991226 | 000 |
| 00888912086257 | K991226 | 000 |
| 00888912086301 | K991226 | 000 |
| 00888912086226 | K991226 | 000 |