The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Checkmate Metatarso-phalangeal (mtp) Arthrodesis System.
| Device ID | K113762 |
| 510k Number | K113762 |
| Device Name: | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-02-06 |
| Summary: | summary |