Home / 510(k) Clearances / K192911

510(k) K192911

Brainlab Compatible K2M Navigation Instruments by K2m, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2019
Date Received
October 15, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by K2m, Inc.

  • 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)
  • K190179 — SAHARA Stabilization System (October 3, 2019)
  • K190584 — CAYMAN LP Plate System (May 15, 2019)
  • K182473 — PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical (December 12, 2018)

Other clearances for product code OLO

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K260222 — Mako Total Knee Application (February 25, 2026)
  • K252989 — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (February 20, 2026)
  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)