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FDA 510(k)

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

K-Number: K231233 · 2023-05-26

Decision Date2023-05-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2023-05-26 under approval number K231233. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Conformis, Inc.. The 510(k) number is K231233.

When was Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS approved by the FDA?

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS received FDA 510(k) clearance on 2023-05-26, under approval number K231233.

What company makes Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is manufactured by Conformis, Inc..

What is the FDA product code for Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

The FDA product code for Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is JWH.

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Official Source

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