K123412 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS. 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 February 13, 2013, 99 days after receiving the submission on November 6, 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 | K123412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 06, 2012 |
| Decision Date | February 13, 2013 |
| Days to Decision | 99 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. |