The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Titan Ti Suture Anchor System.
| Device ID | K111397 |
| 510k Number | K111397 |
| Device Name: | TITAN TI SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2011-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470002683 | K111397 | 000 |
| 00817470002676 | K111397 | 000 |
| 00817470002669 | K111397 | 000 |
| 00817470002652 | K111397 | 000 |