The following data is part of a premarket notification filed by Glw Medical Innovation with the FDA for Fusionframe Ring Lock System.
| Device ID | K200343 |
| 510k Number | K200343 |
| Device Name: | FusionFrame Ring Lock System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | GLW Medical Innovation 300 Sylvan Ave Englewood Cliffs, NJ 07632 |
| Contact | Elijah Wreh |
| Correspondent | Elijah Wreh GLW Medical Innovation 300 Sylvan Ave Englewood Cliffs, NJ 07632 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-11 |
| Decision Date | 2020-09-14 |