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FDA 510(k)

MODIFICATION TO PROVIDENT HIP SYSTEM

K-Number: K002796 · 2000-09-28

ApplicantStelkast Company
Decision Date2000-09-28
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROVIDENT HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2000-09-28 under 510(k) number K002796. 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 MODIFICATION TO PROVIDENT HIP SYSTEM?

MODIFICATION TO PROVIDENT HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-28. The listed applicant is Stelkast Company. The 510(k) number is K002796.

When did MODIFICATION TO PROVIDENT HIP SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO PROVIDENT HIP SYSTEM received FDA 510(k) clearance on 2000-09-28, under 510(k) number K002796.

Who is the listed applicant for MODIFICATION TO PROVIDENT HIP SYSTEM?

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 MODIFICATION TO PROVIDENT HIP SYSTEM?

The FDA product code for MODIFICATION TO PROVIDENT HIP SYSTEM 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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