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FDA 510(k)

BETACONE HIP PROSTHESIS SYSTEM

K-Number: K051826 · 2005-11-18

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2005-11-18
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BETACONE HIP PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K051826. 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 BETACONE HIP PROSTHESIS SYSTEM?

BETACONE HIP PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K051826.

When did BETACONE HIP PROSTHESIS SYSTEM receive FDA 510(k) clearance?

BETACONE HIP PROSTHESIS SYSTEM received FDA 510(k) clearance on 2005-11-18, under 510(k) number K051826.

Who is the listed applicant for BETACONE HIP PROSTHESIS SYSTEM?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETACONE HIP PROSTHESIS SYSTEM?

The FDA product code for BETACONE HIP PROSTHESIS SYSTEM is LWJ.

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Other records listing Waldemar Link GmbH & Co. KG 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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