FDA.report

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
N

Related Records

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

Related GUDID Devices

Primary DIBrandCompanyPublished
08800113399181Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113398306Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399044Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399051Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399068Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399075Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399082Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399099Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399105Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399112Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399129Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399136Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399143Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399150Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399167Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399174Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399334Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399198Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399204Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399211Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399228Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399235Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399242Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399259Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399266Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399273Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399280Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399297Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399303Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01
08800113399310Peridot-EX Expandable Intervertebral body fusion system GBS Commonwealth Co.,Ltd.2023-12-01

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