Home / 510(k) Clearances / K202878

510(k) K202878

Prase-AP Anterior Cervical Plate System by Gbs Commonwealth Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2021
Date Received
September 28, 2020
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 Gbs Commonwealth Co., Ltd.

  • K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Inter (December 20, 2023)
  • K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Inter (November 21, 2023)
  • K232292 — Peridot-EX Expandable Intervertebral Body Fusion System (November 7, 2023)
  • K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Ant (October 13, 2023)
  • K230708 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Ant (May 22, 2023)
  • K213755 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Inter (February 17, 2023)
  • K213980 — Peridot Spinal Interbody System (March 15, 2022)
  • K211205 — Prase-C Anterior Cervical Plate System (August 12, 2021)
  • K202872 — Prase PEEK Anterior Cervical Interbody Spacer (February 4, 2021)
  • K192026 — Peridot Intervertebral body fusion System (November 26, 2019)

Other clearances for product code KWQ

  • K260697 — VyPlate™ Anterior Cervical Plate System (March 27, 2026)
  • 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)