The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Hip Knotless Fixation Implant.
| Device ID | K123240 |
| 510k Number | K123240 |
| Device Name: | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin, TX 78735 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin, TX 78735 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-16 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470003499 | K123240 | 000 |
| 00817470003482 | K123240 | 000 |
| 00817470003475 | K123240 | 000 |
| 00817470003413 | K123240 | 000 |