Home / 510(k) Clearances / K091134

510(k) K091134

CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE by Custom Spine, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2009
Date Received
April 20, 2009
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 Custom Spine, Inc.

  • K143143 — PATHWAY ELIF (July 22, 2015)
  • K132596 — PROPOSED OPTIMUS (April 11, 2014)
  • K120597 — KOMPREDA (May 3, 2013)
  • K111726 — PATHWAY AVID (February 6, 2012)
  • K111774 — PATHWAY MODEL 07XXXX (July 20, 2011)
  • K111099 — ISSYS LP SPINAL FIXATION SYSTEM (May 5, 2011)
  • K101151 — REGENT ANTERIOR CERVICAL PLATE (May 19, 2010)
  • K092904 — PATHWAY IVB/VBR (December 22, 2009)
  • K090566 — PATHWAY AVID (June 1, 2009)
  • K080281 — PATHWAY (May 1, 2008)

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)