The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Q-fix Suture Anchor,1.8mm And 2.8mm / Drill, Drill Guide And Obturator,1.8mm And 2.8mm /bone Punch,2.8mm And Knot Pusher.
| Device ID | K132513 |
| 510k Number | K132513 |
| Device Name: | Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 -0000 |
| Contact | Mitchell Dhority |
| Correspondent | Mitchell Dhority ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 -0000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-09-19 |
| Summary: | summary |