K121630 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM. This device is classified as a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II - Special Controls, product code OSH).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on September 11, 2012, 99 days after receiving the submission on June 4, 2012.
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 | K121630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | June 04, 2012 |
| Decision Date | September 11, 2012 |
| Days to Decision | 99 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. |