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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 the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2016-12-05 under 510(k) 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. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K162127.

When did Bencox M Stem Lateralized & Bencox Mirabo Cup System receive FDA 510(k) clearance?

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

Who is the listed applicant for Bencox M Stem Lateralized & Bencox Mirabo Cup System?

The FDA 510(k) record lists Corentec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Corentec Co., Ltd. as applicant

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Related Devices (Code: LPH)

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.

K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.K252067Velora Acetabular SystemRestor3D, 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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