The following data is part of a premarket notification filed by Eleven Blade Solutions, Inc. with the FDA for Q-fix Suture Anchor, 1.8mm Q-fix Access Tools (drill Guide W/obturator, Drill Bit) 1.8mm.
| Device ID | K122336 |
| 510k Number | K122336 |
| Device Name: | Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ELEVEN BLADE SOLUTIONS, INC. 14734 LA RINCONADA DRIVE Los Gatos, CA 95032 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber ELEVEN BLADE SOLUTIONS, 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 | 2012-08-02 |
| Decision Date | 2013-01-09 |
| Summary: | summary |