The following data is part of a premarket notification filed by Pivot Medical with the FDA for Cinchlock Flex Knotless Suture Anchor.
| Device ID | K151314 |
| 510k Number | K151314 |
| Device Name: | CinchLock Flex Knotless Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Pivot Medical 247 Humboldt Court Sunnyvale, CA 94089 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk Pivot Medical 247 Humboldt Court Sunnyvale, CA 94089 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-07-23 |
| Summary: | summary |