The following data is part of a premarket notification filed by Synchro Medical with the FDA for Toegrip, Implant For Proximal Inter-phalangeal Arthrodesis.
| Device ID | K133477 |
| 510k Number | K133477 |
| Device Name: | TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNCHRO MEDICAL 505 BERKS PLACE West Lawn, PA 19609 |
| Contact | Mark F Schenk |
| Correspondent | Mark F Schenk SYNCHRO MEDICAL 505 BERKS PLACE West Lawn, PA 19609 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-02-10 |
| Summary: | summary |