The following data is part of a premarket notification filed by Foundry Newco Xi, Inc. with the FDA for Cincher-2.6 Suture Anchor Model Fg-001.
| Device ID | K122954 |
| 510k Number | K122954 |
| Device Name: | CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | FOUNDRY NEWCO XI, INC. 14734 LA RINCONADA DRIVE Los Gatos, CA 95032 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber FOUNDRY NEWCO XI, INC. 14734 LA RINCONADA DRIVE Los Gatos, CA 95032 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2012-12-19 |
| Summary: | summary |