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FDA 510(k)

GALILEO CAS/NAV TKR SYSTEM

K-Number: K020298 · 2002-05-20

ApplicantPlus Orthopedics
Decision Date2002-05-20
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALILEO CAS/NAV TKR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2002-05-20 under 510(k) number K020298. 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 GALILEO CAS/NAV TKR SYSTEM?

GALILEO CAS/NAV TKR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-20. The listed applicant is Plus Orthopedics. The 510(k) number is K020298.

When did GALILEO CAS/NAV TKR SYSTEM receive FDA 510(k) clearance?

GALILEO CAS/NAV TKR SYSTEM received FDA 510(k) clearance on 2002-05-20, under 510(k) number K020298.

Who is the listed applicant for GALILEO CAS/NAV TKR SYSTEM?

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

What is the FDA product code for GALILEO CAS/NAV TKR SYSTEM?

The FDA product code for GALILEO CAS/NAV TKR SYSTEM is HAW.

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Other records listing Plus Orthopedics 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.

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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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