The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for The Simple Locking Intramedullary (slim) System.
| Device ID | K192710 |
| 510k Number | K192710 |
| Device Name: | The Simple Locking Intramedullary (Slim) System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Pega Medical Inc. 111 Autoroute Chomeday Laval, CA H7w55j8 |
| Contact | Ariel R. Dujovne |
| Correspondent | Ariel R. Dujovne Pega Medical Inc. 111 Autoroute Chomeday Laval, CA H7w55j8 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-06-24 |