The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Gap Endo-exo Medullary System.
| Device ID | K160545 |
| 510k Number | K160545 |
| Device Name: | GAP ENDO-EXO MEDULLARY SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8 |
| Contact | Ariel R. Dujovne |
| Correspondent | Ariel R. Dujovne PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2016-11-23 |
| Summary: | summary |