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 |