The following data is part of a premarket notification filed by T & R Mfg., Inc. with the FDA for Mts Knee System.
| Device ID | K905613 |
| 510k Number | K905613 |
| Device Name: | MTS KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | T & R MFG., INC. P.O. BOX 33 Red Rock, TX 78662 |
| Contact | Sandor Turanyi |
| Correspondent | Sandor Turanyi T & R MFG., INC. P.O. BOX 33 Red Rock, TX 78662 |
| 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 | 1990-12-14 |
| Decision Date | 1991-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912108829 | K905613 | 000 |
| 00888912108331 | K905613 | 000 |
| 00888912108355 | K905613 | 000 |
| 00888912108379 | K905613 | 000 |
| 00888912108386 | K905613 | 000 |
| 00888912108775 | K905613 | 000 |
| 00888912108782 | K905613 | 000 |
| 00888912108799 | K905613 | 000 |
| 00888912108812 | K905613 | 000 |
| 00888912108324 | K905613 | 000 |