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FDA 510(k)

LUBINUS SP II HIP SYSTEM

K-Number: K953653 · 1995-11-06

ApplicantTurnkey Intergration USA, Inc.
Decision Date1995-11-06
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LUBINUS SP II HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K953653. 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 LUBINUS SP II HIP SYSTEM?

LUBINUS SP II HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K953653.

When did LUBINUS SP II HIP SYSTEM receive FDA 510(k) clearance?

LUBINUS SP II HIP SYSTEM received FDA 510(k) clearance on 1995-11-06, under 510(k) number K953653.

Who is the listed applicant for LUBINUS SP II HIP SYSTEM?

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

What is the FDA product code for LUBINUS SP II HIP SYSTEM?

The FDA product code for LUBINUS SP II HIP SYSTEM is JDG.

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Other records listing Turnkey Intergration USA, Inc. as applicant

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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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