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FDA 510(k)

TRINITY ACETABULAR SYSTEM

K-Number: K103518 · 2011-03-09

ApplicantCorin USA
Decision Date2011-03-09
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRINITY ACETABULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2011-03-09 under 510(k) number K103518. 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 TRINITY ACETABULAR SYSTEM?

TRINITY ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-09. The listed applicant is Corin USA. The 510(k) number is K103518.

When did TRINITY ACETABULAR SYSTEM receive FDA 510(k) clearance?

TRINITY ACETABULAR SYSTEM received FDA 510(k) clearance on 2011-03-09, under 510(k) number K103518.

Who is the listed applicant for TRINITY ACETABULAR SYSTEM?

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

What is the FDA product code for TRINITY ACETABULAR SYSTEM?

The FDA product code for TRINITY ACETABULAR SYSTEM is LWJ.

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Other records listing Corin USA as applicant

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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.K090764NOVATION 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.K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, 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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