The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Speedfix Suture Implant, 3.0mm Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide Model Om-75.
| Device ID | K111399 |
| 510k Number | K111399 |
| Device Name: | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2011-07-20 |
| Summary: | summary |