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FDA 510(k)

(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE

K-Number: K901552 · 1991-06-24

ApplicantNobelpharma USA, Inc.
Decision Date1991-06-24
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K901552. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE?

(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K901552.

When did (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE receive FDA 510(k) clearance?

(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE received FDA 510(k) clearance on 1991-06-24, under 510(k) number K901552.

Who is the listed applicant for (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE?

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

What is the FDA product code for (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE?

The FDA product code for (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE is EJH.

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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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