FDA.reportPublic FDA data

510(k) K234119

Device
UniSpace® Stand-Alone C Cage
Applicant
Innosys Co., Ltd.
510(k) number
K234119
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-19
Date received
2023-12-28
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chae-Hyeon Kim
Address
20, Sandan-Ro 76 Beon-Gil(Rd) Uijeongbu-Si KR 11781 11781

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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