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FDA 510(k)

Tibial baseplate, Tibial insert

K-Number: K222700 · 2022-10-06

Decision Date2022-10-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tibial baseplate, Tibial insert is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2022-10-06 under approval number K222700. 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 Tibial baseplate, Tibial insert?

Tibial baseplate, Tibial insert is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by United Orthopedic Corporation. The 510(k) number is K222700.

When was Tibial baseplate, Tibial insert approved by the FDA?

Tibial baseplate, Tibial insert received FDA 510(k) clearance on 2022-10-06, under approval number K222700.

What company makes Tibial baseplate, Tibial insert?

Tibial baseplate, Tibial insert is manufactured by United Orthopedic Corporation.

What is the FDA product code for Tibial baseplate, Tibial insert?

The FDA product code for Tibial baseplate, Tibial insert 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.