FDA 510(k)

HAtetracell-C Titanium Cervical IBF System

K-Number: K231899 · 2023-10-17

Decision Date2023-10-17

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HAtetracell-C Titanium Cervical IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2023-10-17 under approval number K231899. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAtetracell-C Titanium Cervical IBF System?

HAtetracell-C Titanium Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-10-17. It is manufactured by Innovasis, Inc.. The 510(k) number is K231899.

When was HAtetracell-C Titanium Cervical IBF System approved by the FDA?

HAtetracell-C Titanium Cervical IBF System received FDA 510(k) clearance on 2023-10-17, under approval number K231899.

What company makes HAtetracell-C Titanium Cervical IBF System?

HAtetracell-C Titanium Cervical IBF System is manufactured by Innovasis, Inc..

What is the FDA product code for HAtetracell-C Titanium Cervical IBF System?

The FDA product code for HAtetracell-C Titanium Cervical IBF System is ODP.

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Related Devices (Code: ODP)

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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.