The following data is part of a premarket notification filed by Tgm Medical, Inc. with the FDA for Milestone Revision Knee System (mrks) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm.
| Device ID | K130084 |
| 510k Number | K130084 |
| Device Name: | MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TGM MEDICAL, INC. 5145 Golden Foothill Parkway SUITE 175 El Dorado Hills, CA 95762 |
| Contact | Prakash Pai |
| Correspondent | Prakash Pai TGM MEDICAL, INC. 5145 Golden Foothill Parkway SUITE 175 El Dorado Hills, CA 95762 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2013-05-03 |
| Summary: | summary |