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FDA 510(k)

ORTHOMET TITANIUM HYBRID FEMORAL STEM

K-Number: K945783 · 1995-05-30

ApplicantOrthomet, Inc.
Decision Date1995-05-30
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMET TITANIUM HYBRID FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K945783. 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 ORTHOMET TITANIUM HYBRID FEMORAL STEM?

ORTHOMET TITANIUM HYBRID FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Orthomet, Inc.. The 510(k) number is K945783.

When did ORTHOMET TITANIUM HYBRID FEMORAL STEM receive FDA 510(k) clearance?

ORTHOMET TITANIUM HYBRID FEMORAL STEM received FDA 510(k) clearance on 1995-05-30, under 510(k) number K945783.

Who is the listed applicant for ORTHOMET TITANIUM HYBRID FEMORAL STEM?

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

What is the FDA product code for ORTHOMET TITANIUM HYBRID FEMORAL STEM?

The FDA product code for ORTHOMET TITANIUM HYBRID FEMORAL STEM is JDG.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSERK931333ORTHOMET ACETABULAR CUP 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 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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