The following data is part of a premarket notification filed by Glw, Inc. with the FDA for Artemis Proximal Femoral Nail System.
| Device ID | K201379 |
| 510k Number | K201379 |
| Device Name: | Artemis Proximal Femoral Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | GLW, Inc. 300 Sylvan Avenue Englewood Cliffs, NJ 07632 |
| Contact | Arundhati Radhakrishnan |
| Correspondent | Nancy Lincé Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, CA 95483 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2021-02-19 |