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510(k) K181119

Range (Denali and Mesa) Spinal Systems by K2m, Inc. — Product Code NKB

K181119 is an FDA 510(k) premarket notification submitted by K2m, Inc. for the device "Range (Denali and Mesa) Spinal Systems". The FDA issued a decision of Substantially Equivalent on June 26, 2018. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), 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
June 26, 2018
Date Received
April 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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 NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources