The following data is part of a premarket notification filed by Subchondral Solutions, Inc. with the FDA for S-core Implant System.
| Device ID | K220901 |
| 510k Number | K220901 |
| Device Name: | S-Core Implant System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Subchondral Solutions, Inc. 7146 Edinger Ave. Suite A Huntington Beach, CA 92647 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber Subchondral Solutions, Inc. 7146 Edinger Ave. Suite A Huntington Beach, CA 92647 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-07-29 |