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FDA 510(k)

PIGALILEO TKR BASE V2.3 AND CAS V4.1

K-Number: K090313 · 2009-03-11

ApplicantSmith & Nephew, Inc.
Decision Date2009-03-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PIGALILEO TKR BASE V2.3 AND CAS V4.1 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 2009-03-11 under 510(k) number K090313. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGALILEO TKR BASE V2.3 AND CAS V4.1?

PIGALILEO TKR BASE V2.3 AND CAS V4.1 is a medical device that received FDA 510(k) clearance on 2009-03-11. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K090313.

When did PIGALILEO TKR BASE V2.3 AND CAS V4.1 receive FDA 510(k) clearance?

PIGALILEO TKR BASE V2.3 AND CAS V4.1 received FDA 510(k) clearance on 2009-03-11, under 510(k) number K090313.

Who is the listed applicant for PIGALILEO TKR BASE V2.3 AND CAS V4.1?

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 TKR BASE V2.3 AND CAS V4.1?

The FDA product code for PIGALILEO TKR BASE V2.3 AND CAS V4.1 is OLO.

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Official Source

View on FDA Database →

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