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FDA 510(k)

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE

K-Number: K110054 · 2011-03-24

ApplicantZimmer Cas
Decision Date2011-03-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Cas. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K110054. 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 NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE?

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Zimmer Cas. The 510(k) number is K110054.

When did NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE receive FDA 510(k) clearance?

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE received FDA 510(k) clearance on 2011-03-24, under 510(k) number K110054.

Who is the listed applicant for NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE?

The FDA 510(k) record lists Zimmer Cas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE?

The FDA product code for NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE is OLO.

Related Clinical Trials

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Other records listing Zimmer Cas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131129CAS PSI SHOULDER

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Official Source

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