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FDA 510(k)

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

K-Number: K152084 · 2016-04-29

ApplicantCorentec Co., Ltd.
Decision Date2016-04-29
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2016-04-29 under approval number K152084. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K152084.

When was Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug approved by the FDA?

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug received FDA 510(k) clearance on 2016-04-29, under approval number K152084.

What company makes Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is manufactured by Corentec Co., Ltd..

What is the FDA product code for Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

The FDA product code for Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is LPH.

Related Clinical Trials

NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING

Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System K160157LOSPA Modular Knee System K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K161641LOSPA IS ACP System K192507LOSPA II Knee System

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

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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