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FDA 510(k)

ULTIMA AUGMENTED UHMWPE CUP

K-Number: K950563 · 1995-06-07

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1995-06-07
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMA AUGMENTED UHMWPE CUP is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K950563. 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 AUGMENTED UHMWPE CUP?

ULTIMA AUGMENTED UHMWPE CUP is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K950563.

When did ULTIMA AUGMENTED UHMWPE CUP receive FDA 510(k) clearance?

ULTIMA AUGMENTED UHMWPE CUP received FDA 510(k) clearance on 1995-06-07, under 510(k) number K950563.

Who is the listed applicant for ULTIMA AUGMENTED UHMWPE CUP?

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

What is the FDA product code for ULTIMA AUGMENTED UHMWPE CUP?

The FDA product code for ULTIMA AUGMENTED UHMWPE CUP 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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