K223114 is an FDA 510(k) clearance for the Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Gm Dos Reis Industria E Comerico Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 2, 2023, 303 days after receiving the submission on October 3, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K223114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | August 02, 2023 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| 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 |