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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701091001729 | K133477 | 000 |
| 03701091000265 | K133477 | 000 |
| 03701091000258 | K133477 | 000 |
| 03701091000241 | K133477 | 000 |
| 03701091000234 | K133477 | 000 |
| 03701091000227 | K133477 | 000 |
| 03701091000210 | K133477 | 000 |
| 03701091000203 | K133477 | 000 |
| 03701091000197 | K133477 | 000 |
| 03701091000180 | K133477 | 000 |
| 03701091000173 | K133477 | 000 |
| 03701091000166 | K133477 | 000 |
| 03701091006151 | K133477 | 000 |
| 03701091006144 | K133477 | 000 |
| 03701091006137 | K133477 | 000 |
| 03701091006120 | K133477 | 000 |
| 03701091000272 | K133477 | 000 |
| 03701091000289 | K133477 | 000 |
| 03701091000296 | K133477 | 000 |
| 03701091001712 | K133477 | 000 |
| 03701091001705 | K133477 | 000 |
| 03701091001699 | K133477 | 000 |
| 03701091001682 | K133477 | 000 |
| 03701091001675 | K133477 | 000 |
| 03701091001668 | K133477 | 000 |
| 03701091001651 | K133477 | 000 |
| 03701091001644 | K133477 | 000 |
| 03701091001637 | K133477 | 000 |
| 03701091001620 | K133477 | 000 |
| 03701091001613 | K133477 | 000 |
| 03701091001606 | K133477 | 000 |
| 03701091001590 | K133477 | 000 |
| 03701091001583 | K133477 | 000 |
| 03701091000302 | K133477 | 000 |
| 03701091006113 | K133477 | 000 |