The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Multifix S Ultra Knotless Fixation System.
| Device ID | K153669 |
| 510k Number | K153669 |
| Device Name: | MultiFIX S Ultra Knotless Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ArthoCare Corporation 15285 Alton Parkway, Suite 200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ArthoCare 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 | 2015-12-21 |
| Decision Date | 2016-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556722497 | K153669 | 000 |
| 00885556614211 | K153669 | 000 |
| 00885556614204 | K153669 | 000 |