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FDA 510(k)

MALLORY/HEAD TOTAL HIP SYSTEM

K-Number: K853259 · 1985-11-01

ApplicantBiomet, Inc.
Decision Date1985-11-01
Product CodeKMC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MALLORY/HEAD TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853259. The device is classified under product code KMC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MALLORY/HEAD TOTAL HIP SYSTEM?

MALLORY/HEAD TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Biomet, Inc.. The 510(k) number is K853259.

When did MALLORY/HEAD TOTAL HIP SYSTEM receive FDA 510(k) clearance?

MALLORY/HEAD TOTAL HIP SYSTEM received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853259.

Who is the listed applicant for MALLORY/HEAD TOTAL HIP SYSTEM?

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 MALLORY/HEAD TOTAL HIP SYSTEM?

The FDA product code for MALLORY/HEAD TOTAL HIP SYSTEM is KMC.

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Other records listing Biomet, Inc. as applicant

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K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: KMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K936044ENHANCED MODULAR AUSTIN MOORE HIPZimmer, Inc.K853524APR REVISION HIP PROSTHESIS, FEMORAL COMPONENTIntermedics Orthopedics

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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