The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Q-fix Suture Anchor.
| Device ID | K172165 |
| 510k Number | K172165 |
| Device Name: | Q-Fix Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ArthroCare Corporation 15285 Alton Parkway Suite 200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ArthroCare Corporation 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 | 2017-07-18 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556662618 | K172165 | 000 |