The following data is part of a premarket notification filed by Ignite Orthopedics Llc with the FDA for Ignite Anatomic Shoulder System.
| Device ID | K202716 |
| 510k Number | K202716 |
| Device Name: | Ignite Anatomic Shoulder System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Contact | Matt Purdy |
| Correspondent | Russ Parrott Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Product Code | MBF |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-17 |
| Decision Date | 2021-05-20 |