The following data is part of a premarket notification filed by Pivot Medical with the FDA for Cinchlock Knotless Suture Anchor.
| Device ID | K123651 |
| 510k Number | K123651 |
| Device Name: | CINCHLOCK KNOTLESS SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PIVOT MEDICAL 247 HUMBOLDT CT. Sunnyvale, CA 94089 |
| Contact | Jon Cook |
| Correspondent | Jon Cook PIVOT MEDICAL 247 HUMBOLDT CT. Sunnyvale, CA 94089 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-27 |
| Decision Date | 2013-02-21 |
| Summary: | summary |