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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18400659000854 | K201379 | 000 |
| 18400659000649 | K201379 | 000 |
| 18400659000632 | K201379 | 000 |
| 18400659000601 | K201379 | 000 |
| 18400659000595 | K201379 | 000 |
| 18400659000588 | K201379 | 000 |
| 18400659000571 | K201379 | 000 |
| 18400659000564 | K201379 | 000 |
| 18400659000557 | K201379 | 000 |
| 18400659000540 | K201379 | 000 |
| 18400659000533 | K201379 | 000 |
| 18400659000526 | K201379 | 000 |
| 18400659000519 | K201379 | 000 |
| 18400659000502 | K201379 | 000 |
| 18400659000496 | K201379 | 000 |
| 18400659000489 | K201379 | 000 |
| 18400659000472 | K201379 | 000 |
| 18400659000465 | K201379 | 000 |
| 18400659000656 | K201379 | 000 |
| 18400659000663 | K201379 | 000 |
| 18400659000670 | K201379 | 000 |
| 18400659000847 | K201379 | 000 |
| 18400659000830 | K201379 | 000 |
| 18400659000823 | K201379 | 000 |
| 18400659000816 | K201379 | 000 |
| 18400659000809 | K201379 | 000 |
| 18400659000793 | K201379 | 000 |
| 18400659000786 | K201379 | 000 |
| 18400659000779 | K201379 | 000 |
| 18400659000762 | K201379 | 000 |
| 18400659000755 | K201379 | 000 |
| 18400659000748 | K201379 | 000 |
| 18400659000731 | K201379 | 000 |
| 18400659000724 | K201379 | 000 |
| 18400659000717 | K201379 | 000 |
| 18400659000700 | K201379 | 000 |
| 18400659000694 | K201379 | 000 |
| 18400659000687 | K201379 | 000 |
| 18400659000458 | K201379 | 000 |