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 |