The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Sl-plus And Slr-plus.
| Device ID | K932481 |
| 510k Number | K932481 |
| Device Name: | SL-PLUS AND SLR-PLUS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-24 |
| Decision Date | 1994-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912076418 | K932481 | 000 |
| 00888912075640 | K932481 | 000 |
| 00888912024068 | K932481 | 000 |
| 00888912024044 | K932481 | 000 |
| 00888912023382 | K932481 | 000 |
| 00888912079600 | K932481 | 000 |
| 00888912079594 | K932481 | 000 |
| 00888912079587 | K932481 | 000 |
| 00888912079570 | K932481 | 000 |
| 00888912079563 | K932481 | 000 |
| 00888912079556 | K932481 | 000 |
| 00888912079549 | K932481 | 000 |
| 00888912079532 | K932481 | 000 |
| 00888912079525 | K932481 | 000 |
| 00888912079518 | K932481 | 000 |
| 00888912079501 | K932481 | 000 |
| 00888912079495 | K932481 | 000 |
| 00888912079488 | K932481 | 000 |
| 00888912076500 | K932481 | 000 |
| 00888912076517 | K932481 | 000 |
| 00888912076524 | K932481 | 000 |
| 00888912076401 | K932481 | 000 |
| 00888912076395 | K932481 | 000 |
| 00888912076388 | K932481 | 000 |
| 00888912076364 | K932481 | 000 |
| 00888912024051 | K932481 | 000 |
| 00888912075657 | K932481 | 000 |
| 00888912075626 | K932481 | 000 |
| 00888912087360 | K932481 | 000 |
| 00888912087308 | K932481 | 000 |
| 00888912087292 | K932481 | 000 |
| 00888912087285 | K932481 | 000 |
| 00888912087278 | K932481 | 000 |
| 00888912087254 | K932481 | 000 |
| 00888912076562 | K932481 | 000 |
| 00888912076555 | K932481 | 000 |
| 00888912076548 | K932481 | 000 |
| 00888912076531 | K932481 | 000 |
| 00888912079471 | K932481 | 000 |