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FDA 510(k)

FPC HIP STEM COMPONENT

K-Number: K915391 · 1993-04-30

ApplicantImplantology Corp.
Decision Date1993-04-30
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FPC HIP STEM COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Implantology Corp.. It received FDA 510(k) clearance on 1993-04-30 under 510(k) number K915391. 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 FPC HIP STEM COMPONENT?

FPC HIP STEM COMPONENT is a medical device that received FDA 510(k) clearance on 1993-04-30. The listed applicant is Implantology Corp.. The 510(k) number is K915391.

When did FPC HIP STEM COMPONENT receive FDA 510(k) clearance?

FPC HIP STEM COMPONENT received FDA 510(k) clearance on 1993-04-30, under 510(k) number K915391.

Who is the listed applicant for FPC HIP STEM COMPONENT?

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

What is the FDA product code for FPC HIP STEM COMPONENT?

The FDA product code for FPC HIP STEM COMPONENT is JDG.

Related Clinical Trials

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.

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Other records listing Implantology Corp. 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.

K934729UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATEDK915529FPC/SFPC/RFPC ACETABULAR COMPONENTK915528BHR BIPOLAR FEMORAL HEAD COMPONENTK915527CPS ACETABULAR COMPONENTK915385PPC HIP STEM COMPONENTK924099UFC HIP STEM COMPONENT

View all 9 devices →

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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