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FDA 510(k)

Q SYSTEM 28 HIP STEM

K-Number: K910010 · 1991-03-12

ApplicantTurnkey Intergration USA, Inc.
Decision Date1991-03-12
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Q SYSTEM 28 HIP STEM 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 1991-03-12 under 510(k) number K910010. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q SYSTEM 28 HIP STEM?

Q SYSTEM 28 HIP STEM is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K910010.

When did Q SYSTEM 28 HIP STEM receive FDA 510(k) clearance?

Q SYSTEM 28 HIP STEM received FDA 510(k) clearance on 1991-03-12, under 510(k) number K910010.

Who is the listed applicant for Q SYSTEM 28 HIP STEM?

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 Q SYSTEM 28 HIP STEM?

The FDA product code for Q SYSTEM 28 HIP STEM is LWJ.

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Other records listing Turnkey Intergration USA, 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.

K991405OMNI-FIX, HUMERAL NAILK990523B2C, ESPACE REVISION CUP SYSTEMK990307OMNI-FIX, NAIL SYSTEMK972411LINK CEMENT PLUGK970284ARTOS, DIPLOS SYSTEMK970084LINK CERCLAGE WIRE SYSTEM

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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