The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Speedlock Knotless Fixation Device, 3mm Drill, 3mm+ Drill, Pathfinder Obturator & Sharp Tipped Obturator, Low Profile Dr.
| Device ID | K130196 |
| 510k Number | K130196 |
| Device Name: | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 2301 E Saint Elmo Rd Suite 110 Austin, TX 78744 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORP. 2301 E Saint Elmo Rd Suite 110 Austin, TX 78744 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470012101 | K130196 | 000 |
| 00817470012095 | K130196 | 000 |
| 00817470010558 | K130196 | 000 |
| 00817470001099 | K130196 | 000 |
| 00817470000719 | K130196 | 000 |
| 00817470000672 | K130196 | 000 |
| 00885556724675 | K130196 | 000 |