The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for 5.5mm Multifix S Knotless Fixation Device, 6.5mm Multifix S Knotless Fixation Device, Insertion Guide With Obturator, Ta.
| Device ID | K132590 |
| 510k Number | K132590 |
| Device Name: | 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA |
| 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 | 2013-08-19 |
| Decision Date | 2013-09-17 |
| Summary: | summary |