The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown Tip Speedlock Hip Pathfinder.
| Device ID | K120943 |
| 510k Number | K120943 |
| Device Name: | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 -0000 |
| Contact | Cheryl Fredrick |
| Correspondent | Cheryl Fredrick ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 -0000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-29 |
| Decision Date | 2012-09-21 |
| Summary: | summary |