The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Encore Linear Porous Coated Hip With Ha, Encore Foundation Porous Hip With Ha, Encore Revelation Porous Hip With Ha.
| Device ID | K993943 |
| 510k Number | K993943 |
| Device Name: | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-19 |
| Decision Date | 2000-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912086387 | K993943 | 000 |
| 00888912086370 | K993943 | 000 |
| 00888912168236 | K993943 | 000 |
| 00888912086400 | K993943 | 000 |
| 00888912086394 | K993943 | 000 |
| 00888912086363 | K993943 | 000 |
| 00888912086356 | K993943 | 000 |