Gbs Commonwealth Co., Ltd.

FDA Regulatory Profile

Gbs Commonwealth Co., Ltd. appears in FDA public data with 0 recalls, 14 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 20, 2020 (Official Action Indicated (OAI)). Its most recent 510(k) clearance was granted on Dec 20, 2023.

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Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Known Names

Gbs Commonwealth Co, Gbs Commonwealth, Co

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 20, 2020Geumcheon, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3015136700

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body…Dec 20, 2023
K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body…Nov 21, 2023
K232292Peridot-EX Expandable Intervertebral Body Fusion SystemNov 7, 2023
K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical…Oct 13, 2023
K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical…May 22, 2023
K213755Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body…Feb 17, 2023
K213980Peridot Spinal Interbody SystemMar 15, 2022
K211205Prase-C Anterior Cervical Plate SystemAug 12, 2021
K202872Prase PEEK Anterior Cervical Interbody SpacerFeb 4, 2021
K202878Prase-AP Anterior Cervical Plate SystemJan 29, 2021
K192026Peridot Intervertebral body fusion SystemNov 26, 2019
K190762The JASPER Spinal Fixation System IIJun 19, 2019
K182059Prase MIS Spinal SystemOct 4, 2018
K173645JASPER Spinal Fixation SystemJul 23, 2018