FDA 510(k)

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

K-Number: K083565 · 2009-02-20

Decision Date2009-02-20

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K083565. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0?

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K083565.

When did PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 receive FDA 510(k) clearance?

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 received FDA 510(k) clearance on 2009-02-20, under 510(k) number K083565.

Who is the listed applicant for PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0?

The FDA product code for PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 is HAW.

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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.