The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Adjustable Fixation Device.
| Device ID | K153186 |
| 510k Number | K153186 |
| Device Name: | Adjustable Fixation Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY, NO. 200 Irvine, CA 92618 |
| Contact | Katherine Marcaccio |
| Correspondent | Katherine Marcaccio ARTHROCARE CORP. 15285 ALTON PARKWAY, NO. 200 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556613825 | K153186 | 000 |