The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Y3 Proximal Femoral Plate System.
| Device ID | K163003 |
| 510k Number | K163003 |
| Device Name: | Y3 Proximal Femoral Plate System |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-03-16 |
| Summary: | summary |