K180728 is an FDA 510(k) clearance for the Spinal Elements Cerclage System. This device is classified as a Bone Fixation Cerclage, Sublaminar (Class II - Special Controls, product code OWI).
Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2018, 170 days after receiving the submission on March 20, 2018.
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 | K180728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2018 |
| Decision Date | September 06, 2018 |
| Days to Decision | 170 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. |