The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Multifix S Knotless Fixation System.
| Device ID | K140604 |
| 510k Number | K140604 |
| Device Name: | MULTIFIX S KNOTLESS FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Mitchell Dhority |
| Correspondent | Mitchell Dhority ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470004496 | K140604 | 000 |
| 00817470002546 | K140604 | 000 |
| 00817470002997 | K140604 | 000 |
| 00817470004359 | K140604 | 000 |
| 00817470004403 | K140604 | 000 |
| 00817470004410 | K140604 | 000 |
| 00817470004427 | K140604 | 000 |
| 00817470004434 | K140604 | 000 |
| 00817470004465 | K140604 | 000 |
| 00817470000580 | K140604 | 000 |