The following data is part of a premarket notification filed by Gexfix International Corp. with the FDA for Gexfix External Fixation.
| Device ID | K160972 |
| 510k Number | K160972 |
| Device Name: | Gexfix External Fixation |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Gexfix International Corp. 55 NE Avenue, Suite 501 Boca Raton, FL 33432 |
| Contact | Maurizio Longo |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING S.R.L. PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-06 |
| Decision Date | 2016-12-28 |
| Summary: | summary |