The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Hemicap Patello-femoral Resurfacing System.
| Device ID | K071413 |
| 510k Number | K071413 |
| Device Name: | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Contact | Dawn J Wilson |
| Correspondent | Dawn J Wilson ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-11-09 |
| Summary: | summary |