Home / 510(k) Clearances / K042073

510(k) K042073

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM by Olsen Medical — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
August 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Olsen Medical

  • K130669 — SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEP (December 6, 2013)
  • K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTER (May 23, 2012)
  • K080187 — OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS (May 9, 2008)
  • K072937 — OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET (December 28, 2007)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)