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FDA 510(k)

All Poly Tibial Component

K-Number: K152430 · 2016-04-12

ApplicantUnited Orthopedic Corporation
Decision Date2016-04-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

All Poly Tibial Component is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2016-04-12 under approval number K152430. 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 All Poly Tibial Component?

All Poly Tibial Component is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by United Orthopedic Corporation. The 510(k) number is K152430.

When was All Poly Tibial Component approved by the FDA?

All Poly Tibial Component received FDA 510(k) clearance on 2016-04-12, under approval number K152430.

What company makes All Poly Tibial Component?

All Poly Tibial Component is manufactured by United Orthopedic Corporation.

What is the FDA product code for All Poly Tibial Component?

The FDA product code for All Poly Tibial Component is JWH.

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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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