The following data is part of a premarket notification filed by Alexandria Research Technologies, Llc with the FDA for Tgs Unicompartmental Knee Arthroplasty (tgs Uka) Modular Tibia System.
| Device ID | K101206 |
| 510k Number | K101206 |
| Device Name: | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 13755 FIRST AVENUE NORTH SUITE 100 Plymouth, MN 55441 |
| Contact | Michael Larson |
| Correspondent | Michael Larson ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 13755 FIRST AVENUE NORTH SUITE 100 Plymouth, MN 55441 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-30 |
| Decision Date | 2010-07-23 |
| Summary: | summary |