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510(k) K211205

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2021
Date Received
April 22, 2021
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

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  • K213980 — Peridot Spinal Interbody System (March 15, 2022)
  • K202872 — Prase PEEK Anterior Cervical Interbody Spacer (February 4, 2021)
  • K202878 — Prase-AP Anterior Cervical Plate System (January 29, 2021)
  • K192026 — Peridot Intervertebral body fusion System (November 26, 2019)

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