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FDA 510(k)

UniSpace® Stand-Alone C Cage

K-Number: K234119 · 2024-04-19

ApplicantInnosys Co., Ltd.
Decision Date2024-04-19
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UniSpace® Stand-Alone C Cage is a medical device manufactured by Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under approval number K234119. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniSpace® Stand-Alone C Cage?

UniSpace® Stand-Alone C Cage is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Innosys Co., Ltd.. The 510(k) number is K234119.

When was UniSpace® Stand-Alone C Cage approved by the FDA?

UniSpace® Stand-Alone C Cage received FDA 510(k) clearance on 2024-04-19, under approval number K234119.

What company makes UniSpace® Stand-Alone C Cage?

UniSpace® Stand-Alone C Cage is manufactured by Innosys Co., Ltd..

What is the FDA product code for UniSpace® Stand-Alone C Cage?

The FDA product code for UniSpace® Stand-Alone C Cage is OVE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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