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 |