K101184 is an FDA 510(k) clearance for the TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on May 18, 2010, 20 days after receiving the submission on April 28, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K101184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2010 |
| Decision Date | May 18, 2010 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |