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FDA 510(k)

SUFACE REPLACEMENT ELBOW

K-Number: K820957 · 1982-07-02

ApplicantHowmedica Corp.
Decision Date1982-07-02
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUFACE REPLACEMENT ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K820957. 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 SUFACE REPLACEMENT ELBOW?

SUFACE REPLACEMENT ELBOW is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Howmedica Corp.. The 510(k) number is K820957.

When did SUFACE REPLACEMENT ELBOW receive FDA 510(k) clearance?

SUFACE REPLACEMENT ELBOW received FDA 510(k) clearance on 1982-07-02, under 510(k) number K820957.

Who is the listed applicant for SUFACE REPLACEMENT ELBOW?

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

What is the FDA product code for SUFACE REPLACEMENT ELBOW?

The FDA product code for SUFACE REPLACEMENT ELBOW 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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