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FDA 510(k)

BIOMET BIPOLAR PROSTHESIS

K-Number: K833175 · 1983-12-22

ApplicantBiomet, Inc.
Decision Date1983-12-22
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET BIPOLAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833175. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET BIPOLAR PROSTHESIS?

BIOMET BIPOLAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Biomet, Inc.. The 510(k) number is K833175.

When did BIOMET BIPOLAR PROSTHESIS receive FDA 510(k) clearance?

BIOMET BIPOLAR PROSTHESIS received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833175.

Who is the listed applicant for BIOMET BIPOLAR PROSTHESIS?

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 BIOMET BIPOLAR PROSTHESIS?

The FDA product code for BIOMET BIPOLAR PROSTHESIS is KWY.

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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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