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FDA 510(k)

UTF Stem, reduced, #0, #00

K-Number: K163193 · 2017-06-08

Decision Date2017-06-08
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UTF Stem, reduced, #0, #00 is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-06-08 under approval number K163193. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTF Stem, reduced, #0, #00?

UTF Stem, reduced, #0, #00 is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by United Orthopedic Corporation. The 510(k) number is K163193.

When was UTF Stem, reduced, #0, #00 approved by the FDA?

UTF Stem, reduced, #0, #00 received FDA 510(k) clearance on 2017-06-08, under approval number K163193.

What company makes UTF Stem, reduced, #0, #00?

UTF Stem, reduced, #0, #00 is manufactured by United Orthopedic Corporation.

What is the FDA product code for UTF Stem, reduced, #0, #00?

The FDA product code for UTF Stem, reduced, #0, #00 is LPH.

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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.