The following data is part of a premarket notification filed by Subchondral Solutions with the FDA for S4 Screw System™.
| Device ID | K162171 |
| 510k Number | K162171 |
| Device Name: | S4 Screw System™ |
| Classification | Screw, Fixation, Bone |
| Applicant | SUBCHONDRAL SOLUTIONS 147 HILLBROOK DRIVE Los Gatos, CA 95032 |
| Contact | Sheryl Mccoy |
| Correspondent | Karen E. Warden BACKROADS CONSULTING INC. PO BOX 566 Chesterland, OH 44026 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-03 |
| Decision Date | 2017-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850017962276 | K162171 | 000 |
| 10850017962016 | K162171 | 000 |
| 10850017962009 | K162171 | 000 |
| 00850017962613 | K162171 | 000 |
| 10850017962580 | K162171 | 000 |
| 00850017962569 | K162171 | 000 |
| 00850017962552 | K162171 | 000 |
| 00850017962545 | K162171 | 000 |
| 00850017962538 | K162171 | 000 |
| 00850017962521 | K162171 | 000 |
| 00850017962514 | K162171 | 000 |
| 00850017962507 | K162171 | 000 |
| 00850017962491 | K162171 | 000 |
| 00850017962477 | K162171 | 000 |
| 00850017962460 | K162171 | 000 |
| 00850017962453 | K162171 | 000 |
| 00850017962576 | K162171 | 000 |
| 10850017962023 | K162171 | 000 |
| 10850017962030 | K162171 | 000 |
| 10850017962269 | K162171 | 000 |
| 00850017962255 | K162171 | 000 |
| 10850017962245 | K162171 | 000 |
| 10850017962238 | K162171 | 000 |
| 10850017962221 | K162171 | 000 |
| 10850017962214 | K162171 | 000 |
| 10850017962139 | K162171 | 000 |
| 10850017962122 | K162171 | 000 |
| 10850017962115 | K162171 | 000 |
| 10850017962108 | K162171 | 000 |
| 10850017962092 | K162171 | 000 |
| 10850017962085 | K162171 | 000 |
| 10850017962078 | K162171 | 000 |
| 10850017962061 | K162171 | 000 |
| 10850017962054 | K162171 | 000 |
| 10850017962047 | K162171 | 000 |
| 00850017962484 | K162171 | 000 |