The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Knee System.
| Device ID | K964008 |
| 510k Number | K964008 |
| Device Name: | FOUNDATION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1996-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912109710 | K964008 | 000 |
| 00888912110556 | K964008 | 000 |
| 00888912110549 | K964008 | 000 |
| 00888912110532 | K964008 | 000 |
| 00888912110525 | K964008 | 000 |
| 00888912110310 | K964008 | 000 |
| 00888912110303 | K964008 | 000 |
| 00888912110297 | K964008 | 000 |
| 00888912110280 | K964008 | 000 |
| 00888912110266 | K964008 | 000 |
| 00888912110259 | K964008 | 000 |
| 00888912110242 | K964008 | 000 |
| 00888912110235 | K964008 | 000 |
| 00888912110228 | K964008 | 000 |
| 00888912110570 | K964008 | 000 |
| 00888912110587 | K964008 | 000 |
| 00888912109703 | K964008 | 000 |
| 00888912109697 | K964008 | 000 |
| 00888912109680 | K964008 | 000 |
| 00888912109673 | K964008 | 000 |
| 00888912109666 | K964008 | 000 |
| 00888912109659 | K964008 | 000 |
| 00888912109642 | K964008 | 000 |
| 00888912109635 | K964008 | 000 |
| 00888912109611 | K964008 | 000 |
| 00888912109604 | K964008 | 000 |
| 00888912109598 | K964008 | 000 |
| 00888912110600 | K964008 | 000 |
| 00888912110594 | K964008 | 000 |
| 00888912110563 | K964008 | 000 |