The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Grs Glenoid Resurfacing System.
| Device ID | K091196 |
| 510k Number | K091196 |
| Device Name: | GRS GLENOID RESURFACING SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M528G2032520W0 | K091196 | 000 |
| M528G00002000 | K091196 | 000 |
| M528G00714000 | K091196 | 000 |
| M528G2032010A0 | K091196 | 000 |
| M528G2032010W0 | K091196 | 000 |
| M528G2032015A0 | K091196 | 000 |
| M528G2032015W0 | K091196 | 000 |
| M528G2032515A0 | K091196 | 000 |
| M528G2032515W0 | K091196 | 000 |
| M528G2032520A0 | K091196 | 000 |
| M528G00001000 | K091196 | 000 |