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FDA 510(k)

40-42mm BiPolar Head and 22mm Femoral Head

K-Number: K163081 · 2018-01-29

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2018-01-29
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

40-42mm BiPolar Head and 22mm Femoral Head is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-29 under approval number K163081. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 40-42mm BiPolar Head and 22mm Femoral Head?

40-42mm BiPolar Head and 22mm Femoral Head is a medical device that received FDA 510(k) clearance on 2018-01-29. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K163081.

When was 40-42mm BiPolar Head and 22mm Femoral Head approved by the FDA?

40-42mm BiPolar Head and 22mm Femoral Head received FDA 510(k) clearance on 2018-01-29, under approval number K163081.

What company makes 40-42mm BiPolar Head and 22mm Femoral Head?

40-42mm BiPolar Head and 22mm Femoral Head is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for 40-42mm BiPolar Head and 22mm Femoral Head?

The FDA product code for 40-42mm BiPolar Head and 22mm Femoral Head is KWY.

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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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