K122877 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM, SMALL STATURE. 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 May 8, 2013, 231 days after receiving the submission on September 19, 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 | K122877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2012 |
| Decision Date | May 08, 2013 |
| Days to Decision | 231 days |
| Submission Type | Special |
| 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. |