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FDA 510(k)

Bencox M Stem Lateralized & Bencox Mirabo Cup System

K-Number: K162127 · 2016-12-05

ApplicantCorentec Co., Ltd.
Decision Date2016-12-05
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bencox M Stem Lateralized & Bencox Mirabo Cup System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2016-12-05 under approval number K162127. 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 Lateralized & Bencox Mirabo Cup System?

Bencox M Stem Lateralized & Bencox Mirabo Cup System is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K162127.

When was Bencox M Stem Lateralized & Bencox Mirabo Cup System approved by the FDA?

Bencox M Stem Lateralized & Bencox Mirabo Cup System received FDA 510(k) clearance on 2016-12-05, under approval number K162127.

What company makes Bencox M Stem Lateralized & Bencox Mirabo Cup System?

Bencox M Stem Lateralized & Bencox Mirabo Cup System is manufactured by Corentec Co., Ltd..

What is the FDA product code for Bencox M Stem Lateralized & Bencox Mirabo Cup System?

The FDA product code for Bencox M Stem Lateralized & Bencox Mirabo Cup System is LPH.

Other Devices by Corentec Co., Ltd.

K160157LOSPA Modular Knee System K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K161641LOSPA IS ACP System K192507LOSPA II Knee System

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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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