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FDA 510(k)

FEMORAL CEMENT RESTRICTOR

K-Number: K800144 · 1980-02-19

ApplicantBiomet, Inc.
Decision Date1980-02-19
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEMORAL CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1980-02-19 under 510(k) number K800144. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMORAL CEMENT RESTRICTOR?

FEMORAL CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1980-02-19. The listed applicant is Biomet, Inc.. The 510(k) number is K800144.

When did FEMORAL CEMENT RESTRICTOR receive FDA 510(k) clearance?

FEMORAL CEMENT RESTRICTOR received FDA 510(k) clearance on 1980-02-19, under 510(k) number K800144.

Who is the listed applicant for FEMORAL CEMENT RESTRICTOR?

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 FEMORAL CEMENT RESTRICTOR?

The FDA product code for FEMORAL CEMENT RESTRICTOR is JDS.

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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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