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FDA 510(k)

United U2 femoral head, 22mm delta ceramic head

K-Number: K221675 · 2022-11-04

ApplicantUnited Orthopedic Corporation
Decision Date2022-11-04
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

United U2 femoral head, 22mm delta ceramic head is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2022-11-04 under approval number K221675. 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 United U2 femoral head, 22mm delta ceramic head?

United U2 femoral head, 22mm delta ceramic head is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by United Orthopedic Corporation. The 510(k) number is K221675.

When was United U2 femoral head, 22mm delta ceramic head approved by the FDA?

United U2 femoral head, 22mm delta ceramic head received FDA 510(k) clearance on 2022-11-04, under approval number K221675.

What company makes United U2 femoral head, 22mm delta ceramic head?

United U2 femoral head, 22mm delta ceramic head is manufactured by United Orthopedic Corporation.

What is the FDA product code for United U2 femoral head, 22mm delta ceramic head?

The FDA product code for United U2 femoral head, 22mm delta ceramic head is LPH.

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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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