The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Knotless Fixation Device; 3.0mm Drill; Sharp Tipped Obturator; Low Profile Drill Guidde.
| Device ID | K111044 |
| 510k Number | K111044 |
| Device Name: | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 15285 ALTON PARKWAY SUITE 209 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORPORATION 15285 ALTON PARKWAY SUITE 209 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2011-08-09 |
| Summary: | summary |