K231333 is an FDA 510(k) clearance for the STRETTO™ Cable System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 4, 2023, 88 days after receiving the submission on May 8, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K231333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | August 04, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |