The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Toemotion.
Device ID | K132496 |
510k Number | K132496 |
Device Name: | ARTHROSURFACE TOEMOTION |
Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
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 | LZJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-09 |
Decision Date | 2014-02-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M5289P15S180A0 | K132496 | 000 |
M5289P15PB02A0 | K132496 | 000 |
M5289P15PB01A0 | K132496 | 000 |
M5289P15PA02A0 | K132496 | 000 |
M5289P15PA01A0 | K132496 | 000 |
M5289P1501000 | K132496 | 000 |