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FDA 510(k)

TRI-FIT FEMORAL STEM

K-Number: K010243 · 2001-02-15

ApplicantCorin USA
Decision Date2001-02-15
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRI-FIT FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K010243. 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 TRI-FIT FEMORAL STEM?

TRI-FIT FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Corin USA. The 510(k) number is K010243.

When did TRI-FIT FEMORAL STEM receive FDA 510(k) clearance?

TRI-FIT FEMORAL STEM received FDA 510(k) clearance on 2001-02-15, under 510(k) number K010243.

Who is the listed applicant for TRI-FIT FEMORAL STEM?

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 TRI-FIT FEMORAL STEM?

The FDA product code for TRI-FIT FEMORAL STEM 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.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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