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FDA 510(k)

Tailored-H Cervical Stand Alone System

K-Number: K222903 · 2022-11-18

ApplicantBespoke Technologies, LLC
Decision Date2022-11-18
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tailored-H Cervical Stand Alone System is a medical device manufactured by Bespoke Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under approval number K222903. 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 Tailored-H Cervical Stand Alone System?

Tailored-H Cervical Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Bespoke Technologies, LLC. The 510(k) number is K222903.

When was Tailored-H Cervical Stand Alone System approved by the FDA?

Tailored-H Cervical Stand Alone System received FDA 510(k) clearance on 2022-11-18, under approval number K222903.

What company makes Tailored-H Cervical Stand Alone System?

Tailored-H Cervical Stand Alone System is manufactured by Bespoke Technologies, LLC.

What is the FDA product code for Tailored-H Cervical Stand Alone System?

The FDA product code for Tailored-H Cervical Stand Alone System is OVE.

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Related Devices (Code: 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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