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FDA 510(k)

DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT

K-Number: K953268 · 1996-01-17

ApplicantStelkast Company
Decision Date1996-01-17
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K953268. 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 DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT?

DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Stelkast Company. The 510(k) number is K953268.

When did DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT receive FDA 510(k) clearance?

DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT received FDA 510(k) clearance on 1996-01-17, under 510(k) number K953268.

Who is the listed applicant for DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT?

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

What is the FDA product code for DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT?

The FDA product code for DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT is LWJ.

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Other records listing Stelkast Company 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.

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMK122773CROSS-OVER ACETABULAR SHELL & LINERK094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAY

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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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