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FDA 510(k)

BRIGHAM II TOTAL HIP SYSTEM

K-Number: K812687 · 1981-10-02

ApplicantHexcel Medical
Decision Date1981-10-02
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BRIGHAM II TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hexcel Medical. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812687. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHAM II TOTAL HIP SYSTEM?

BRIGHAM II TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Hexcel Medical. The 510(k) number is K812687.

When did BRIGHAM II TOTAL HIP SYSTEM receive FDA 510(k) clearance?

BRIGHAM II TOTAL HIP SYSTEM received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812687.

Who is the listed applicant for BRIGHAM II TOTAL HIP SYSTEM?

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

What is the FDA product code for BRIGHAM II TOTAL HIP SYSTEM?

The FDA product code for BRIGHAM II TOTAL HIP SYSTEM is JDG.

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Other records listing Hexcel Medical 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.

K840416HEXCELITEK820890URETHANE ORTHOPAEDIC CASTING TAPEK812669SEATTLE II TOTAL HIP SYSTEMK812068PROPOSED CONTROLS FOR DOSIMETRIC RELEASEK811164URETHANE ORTHOPAEDIC CASTING TAPEK810957MARCOVE INTRAMEDULLARY ROD

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Related Devices (Code: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast CompanyK992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USAK962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.

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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