K200097 is an FDA 510(k) clearance for the Response BandLoc Spinal Fixation. This device is classified as a Bone Fixation Cerclage, Sublaminar (Class II - Special Controls, product code OWI).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on March 16, 2020, 60 days after receiving the submission on January 16, 2020.
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 | K200097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2020 |
| Decision Date | March 16, 2020 |
| Days to Decision | 60 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. |