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FDA 510(k)

PROFORM CEMENTED FEMORAL COMPONENT

K-Number: K951083 · 1995-05-22

ApplicantStelkast Company
Decision Date1995-05-22
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PROFORM CEMENTED FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K951083. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PROFORM CEMENTED FEMORAL COMPONENT?

PROFORM CEMENTED FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Stelkast Company. The 510(k) number is K951083.

When did PROFORM CEMENTED FEMORAL COMPONENT receive FDA 510(k) clearance?

PROFORM CEMENTED FEMORAL COMPONENT received FDA 510(k) clearance on 1995-05-22, under 510(k) number K951083.

Who is the listed applicant for PROFORM CEMENTED FEMORAL COMPONENT?

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

What is the FDA product code for PROFORM CEMENTED FEMORAL COMPONENT?

The FDA product code for PROFORM CEMENTED FEMORAL COMPONENT is JDG.

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Other records listing Stelkast Company 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.

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMK122773CROSS-OVER ACETABULAR SHELL & LINERK094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAY

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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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