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510(k) K131784

RANGE SPINAL SYSTEM by K2m, Inc. — Product Code OSH

K131784 is an FDA 510(k) premarket notification submitted by K2m, Inc. for the device "RANGE SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 2013. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. K2m, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2013
Date Received
June 18, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

Other clearances by K2m, Inc.

  • K260546 — Q Pedicle Instruments (March 17, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K202528 — Cannulated Power Driver Attachment (October 26, 2020)
  • K201006 — K2M Navigation Instruments (August 7, 2020)
  • K193203 — MOJAVE Expandable Interbody System (February 18, 2020)
  • K193129 — Yukon OCT Spinal System (February 7, 2020)
  • K192911 — Brainlab Compatible K2M Navigation Instruments (November 14, 2019)
  • K190179 — SAHARA Stabilization System (October 3, 2019)

Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K140276 — CD HORIZON SPINAL SYSTEM (March 13, 2014)
  • K132574 — PASS LP SPINAL SYSTEM (November 8, 2013)
  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 2013)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K131321 — CD HORIZON SPINAL SYSTEM (June 5, 2013)
  • K124058 — CREO STABILIZATION SYSTEM (May 13, 2013)
  • K131030 — RANGE SPINAL SYSTEM (May 9, 2013)

FDA data resources