The following data is part of a premarket notification filed by Ross Creek Medical Inc. with the FDA for Spin-loc Suture Anchor System Fg-0302-01,fg-0305-01.
| Device ID | K090530 |
| 510k Number | K090530 |
| Device Name: | SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ROSS CREEK MEDICAL INC. 14734 LA RINCONADA DRIVE Los Gatos, CA 95032 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber ROSS CREEK MEDICAL 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 | 2009-02-27 |
| Decision Date | 2009-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613252017579 | K090530 | 000 |