The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Q-fix Suture Anchor, 1.8mm; Q-fix Suture Anchor, 2.8mm; Drill, Drill Guide And Obturator, 1.8mm & 2.8mm, Firstpass Sutu.
| Device ID | K133727 |
| 510k Number | K133727 |
| Device Name: | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Mitchell Dhority |
| Correspondent | Mitchell Dhority ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-06 |
| Decision Date | 2014-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470011029 | K133727 | 000 |
| 00817470011012 | K133727 | 000 |
| 00885556724644 | K133727 | 000 |
| 00885556724606 | K133727 | 000 |
| 00885556885406 | K133727 | 000 |
| 00885556885390 | K133727 | 000 |
| 00885556885383 | K133727 | 000 |