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FDA 510(k)

MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS

K-Number: K945115 · 1995-05-02

ApplicantBiomet, Inc.
Decision Date1995-05-02
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K945115. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS?

MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Biomet, Inc.. The 510(k) number is K945115.

When did MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS receive FDA 510(k) clearance?

MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS received FDA 510(k) clearance on 1995-05-02, under 510(k) number K945115.

Who is the listed applicant for MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS?

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 MODULAR CALCAR REPACEMENT COMPONENTS?

The FDA product code for MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS is JDI.

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Other records listing Biomet, Inc. as applicant

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.

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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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