K190289 is an FDA 510(k) clearance for the Karma® Fixation 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 April 3, 2019, 51 days after receiving the submission on February 11, 2019.
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 | K190289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | April 03, 2019 |
| Days to Decision | 51 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. |