The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Unicap Unicompartmental Knee Resurfacing Prosthesis.
| Device ID | K050373 |
| 510k Number | K050373 |
| Device Name: | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Contact | Steven Ek |
| Correspondent | Steven Ek ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2005-10-11 |
| Summary: | summary |