The following data is part of a premarket notification filed by Ignite Orthopedics Llc with the FDA for Ignite Stemless Anatomic Shoulder System.
| Device ID | K203108 |
| 510k Number | K203108 |
| Device Name: | Ignite Stemless Anatomic Shoulder System |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Contact | Matt Purdy |
| Correspondent | Russ Parott Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-15 |
| Decision Date | 2021-07-16 |