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FDA 510(k)

FOUNDATION TEXTURED STEM

K-Number: K952297 · 1995-07-17

ApplicantEncore Orthopedics, Inc.
Decision Date1995-07-17
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION TEXTURED STEM is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K952297. 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 FOUNDATION TEXTURED STEM?

FOUNDATION TEXTURED STEM is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K952297.

When did FOUNDATION TEXTURED STEM receive FDA 510(k) clearance?

FOUNDATION TEXTURED STEM received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952297.

Who is the listed applicant for FOUNDATION TEXTURED STEM?

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

What is the FDA product code for FOUNDATION TEXTURED STEM?

The FDA product code for FOUNDATION TEXTURED STEM is LWJ.

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Other records listing Encore Orthopedics, 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.

K0329053DKNEE POROUS COATED FEMORAL COMPONENTK0201143D KNEEK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP 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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