K133482 is an FDA 510(k) clearance for the SILC FIXATION SYSTEM. This device is classified as a Bone Fixation Cerclage, Sublaminar (Class II - Special Controls, product code OWI).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on May 21, 2014, 189 days after receiving the submission on November 13, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010. Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion..
| 510(k) Number | K133482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2013 |
| Decision Date | May 21, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWI — Bone Fixation Cerclage, Sublaminar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |
| Definition | Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion. |