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FDA 510(k)

ABC TOTAL ELBOW PROTHESIS

K-Number: K972691 · 1997-10-15

ApplicantBiomet, Inc.
Decision Date1997-10-15
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABC TOTAL ELBOW PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1997-10-15 under 510(k) number K972691. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABC TOTAL ELBOW PROTHESIS?

ABC TOTAL ELBOW PROTHESIS is a medical device that received FDA 510(k) clearance on 1997-10-15. The listed applicant is Biomet, Inc.. The 510(k) number is K972691.

When did ABC TOTAL ELBOW PROTHESIS receive FDA 510(k) clearance?

ABC TOTAL ELBOW PROTHESIS received FDA 510(k) clearance on 1997-10-15, under 510(k) number K972691.

Who is the listed applicant for ABC TOTAL ELBOW PROTHESIS?

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

What is the FDA product code for ABC TOTAL ELBOW PROTHESIS?

The FDA product code for ABC TOTAL ELBOW PROTHESIS is JDB.

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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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