The following data is part of a premarket notification filed by Subchondral Solutions, Inc. with the FDA for S4 Screw System.
| Device ID | K191995 |
| 510k Number | K191995 |
| Device Name: | S4 Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Subchondral Solutions, Inc. 147 Hillbrook Drive Los Gatos, CA 95032 |
| Contact | Sheryl Mccoy |
| Correspondent | Michael Kolber Subchondral Solutions, Inc. 147 Hillbrook Drive Los Gatos, CA 95032 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-26 |
| Decision Date | 2020-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850017962207 | K191995 | 000 |
| 10850017962597 | K191995 | 000 |
| 10850017962283 | K191995 | 000 |
| 10850017962290 | K191995 | 000 |
| 10850017962306 | K191995 | 000 |
| 10850017962313 | K191995 | 000 |
| 00850017962323 | K191995 | 000 |
| 10850017962337 | K191995 | 000 |
| 10850017962344 | K191995 | 000 |
| 10850017962146 | K191995 | 000 |
| 10850017962153 | K191995 | 000 |
| 10850017962160 | K191995 | 000 |
| 10850017962177 | K191995 | 000 |
| 10850017962184 | K191995 | 000 |
| 10850017962191 | K191995 | 000 |
| 10850017962436 | K191995 | 000 |