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FDA 510(k)

KERBOULL CROSS

K-Number: K972928 · 1997-11-03

ApplicantHowmedica, Inc.
Decision Date1997-11-03
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KERBOULL CROSS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-11-03 under 510(k) number K972928. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KERBOULL CROSS?

KERBOULL CROSS is a medical device that received FDA 510(k) clearance on 1997-11-03. The listed applicant is Howmedica, Inc.. The 510(k) number is K972928.

When did KERBOULL CROSS receive FDA 510(k) clearance?

KERBOULL CROSS received FDA 510(k) clearance on 1997-11-03, under 510(k) number K972928.

Who is the listed applicant for KERBOULL CROSS?

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

What is the FDA product code for KERBOULL CROSS?

The FDA product code for KERBOULL CROSS is JDI.

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Other records listing Howmedica, Inc. as applicant

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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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