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FDA 510(k)

ULTIMA TPS CEMENTED STEM

K-Number: K965198 · 1997-07-23

ApplicantJohnson & Johnson International
Decision Date1997-07-23
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMA TPS CEMENTED STEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson International. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K965198. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA TPS CEMENTED STEM?

ULTIMA TPS CEMENTED STEM is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Johnson & Johnson International. The 510(k) number is K965198.

When did ULTIMA TPS CEMENTED STEM receive FDA 510(k) clearance?

ULTIMA TPS CEMENTED STEM received FDA 510(k) clearance on 1997-07-23, under 510(k) number K965198.

Who is the listed applicant for ULTIMA TPS CEMENTED STEM?

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

What is the FDA product code for ULTIMA TPS CEMENTED STEM?

The FDA product code for ULTIMA TPS CEMENTED STEM is KWL.

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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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