The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Nexgen Tmt Tibia, Models 00-5886-xxyy, 05-120-xxyy-0.
| Device ID | K012866 |
| 510k Number | K012866 |
| Device Name: | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2001-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024310230 | K012866 | 000 |
| 00889024310100 | K012866 | 000 |
| 00889024310094 | K012866 | 000 |
| 00889024310087 | K012866 | 000 |
| 00889024310070 | K012866 | 000 |
| 00889024310063 | K012866 | 000 |
| 00889024310056 | K012866 | 000 |
| 00889024310049 | K012866 | 000 |
| 00889024310032 | K012866 | 000 |
| 00889024310025 | K012866 | 000 |
| 00889024310018 | K012866 | 000 |
| 00889024310117 | K012866 | 000 |
| 00889024310124 | K012866 | 000 |
| 00889024310223 | K012866 | 000 |
| 00889024310216 | K012866 | 000 |
| 00889024310209 | K012866 | 000 |
| 00889024310193 | K012866 | 000 |
| 00889024310186 | K012866 | 000 |
| 00889024310179 | K012866 | 000 |
| 00889024310162 | K012866 | 000 |
| 00889024310155 | K012866 | 000 |
| 00889024310148 | K012866 | 000 |
| 00889024310131 | K012866 | 000 |
| 00889024310001 | K012866 | 000 |