The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Keystone Hip.
| Device ID | K000521 |
| 510k Number | K000521 |
| Device Name: | KEYSTONE HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-16 |
| Decision Date | 2000-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912086943 | K000521 | 000 |
| 00888912086714 | K000521 | 000 |
| 00888912086691 | K000521 | 000 |
| 00888912086684 | K000521 | 000 |
| 00888912086677 | K000521 | 000 |
| 00888912086660 | K000521 | 000 |
| 00888912086653 | K000521 | 000 |
| 00888912086646 | K000521 | 000 |
| 00888912086639 | K000521 | 000 |
| 00888912086622 | K000521 | 000 |
| 00888912086615 | K000521 | 000 |
| 00888912086608 | K000521 | 000 |
| 00888912086592 | K000521 | 000 |
| 00888912086585 | K000521 | 000 |
| 00888912086561 | K000521 | 000 |
| 00888912086738 | K000521 | 000 |
| 00888912086745 | K000521 | 000 |
| 00888912086929 | K000521 | 000 |
| 00888912086912 | K000521 | 000 |
| 00888912086905 | K000521 | 000 |
| 00888912086899 | K000521 | 000 |
| 00888912086875 | K000521 | 000 |
| 00888912086868 | K000521 | 000 |
| 00888912086844 | K000521 | 000 |
| 00888912086837 | K000521 | 000 |
| 00888912086813 | K000521 | 000 |
| 00888912086806 | K000521 | 000 |
| 00888912086783 | K000521 | 000 |
| 00888912086776 | K000521 | 000 |
| 00888912086769 | K000521 | 000 |
| 00888912086752 | K000521 | 000 |
| 00888912086547 | K000521 | 000 |