FDA.reportPublic FDA data

510(k) K232292

Device
Peridot-EX Expandable Intervertebral Body Fusion System
Applicant
Gbs Commonwealth Co., Ltd.
510(k) number
K232292
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-07
Date received
2023-08-01
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jimmy Kim
Address
C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro Geumcheon-Gu KR 08507 08507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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