K130655 is an FDA 510(k) clearance for the RESPONSE SPINE SYSTEM. This device is classified as a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II - Special Controls, product code OSH).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on May 8, 2013, 57 days after receiving the submission on March 12, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis..
| 510(k) Number | K130655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2013 |
| Decision Date | May 08, 2013 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis. |