The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Knotless Fixation System.
| Device ID | K153313 |
| 510k Number | K153313 |
| Device Name: | SpeedLock Knotless Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 15285 ALTON PARWAY, SUITE 200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORPORATION 15285 ALTON PARWAY, 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 | 2015-11-17 |
| Decision Date | 2015-12-11 |
| Summary: | summary |