The following data is part of a premarket notification filed by Glw Medical Inc with the FDA for Apollo Ankle Fracture Plating System.
| Device ID | K213005 |
| 510k Number | K213005 |
| Device Name: | Apollo Ankle Fracture Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | GLW Medical Inc 300 Sylvan Ave Englewood Cliff, NJ 07632 |
| Contact | Arundhati Radhakrishnan |
| Correspondent | Cheryl Wagoner Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington, NC 28409 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-03-11 |