Home / 510(k) Clearances / K151553

510(k) K151553

Anterior Cervical Plate System by Osteomed Implantes, Ltda — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2016
Date Received
June 9, 2015
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 Osteomed Implantes, Ltda

  • K143572 — Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Mai (June 10, 2015)
  • K150294 — DPZ Pedicular Fixation System (June 5, 2015)

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)