The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Wrist Hemiarthroplasty System.
| Device ID | K141920 |
| 510k Number | K141920 |
| Device Name: | Wrist Hemiarthroplasty System |
| Classification | Prosthesis, Wrist, Carpal Lunate |
| 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 | KWN |
| CFR Regulation Number | 888.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5288W950016W0 | K141920 | 000 |
| M5288W153523W0 | K141920 | 000 |
| M5288W153517W0 | K141920 | 000 |
| M5288W152223W0 | K141920 | 000 |
| M5288W152217W0 | K141920 | 000 |
| M5288W123517W0 | K141920 | 000 |
| M5288W122217W0 | K141920 | 000 |