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FDA 510(k)

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM

K-Number: K962002 · 1996-08-08

ApplicantExactech, Inc.
Decision Date1996-08-08
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K962002. 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 AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM?

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Exactech, Inc.. The 510(k) number is K962002.

When did AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM receive FDA 510(k) clearance?

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM received FDA 510(k) clearance on 1996-08-08, under 510(k) number K962002.

Who is the listed applicant for AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM?

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

What is the FDA product code for AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM?

The FDA product code for AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM is JDG.

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Other records listing Exactech, Inc. as applicant

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K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

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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 USAK955171NEXLOCK FEMORAL STEMNexmed, 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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