Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BENCOX Mirabo Z Cup Cortinium

K-Number: K210614 · 2022-05-24

ApplicantCorentec Co., Ltd.
Decision Date2022-05-24
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BENCOX Mirabo Z Cup Cortinium is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2022-05-24 under approval number K210614. 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 Mirabo Z Cup Cortinium?

BENCOX Mirabo Z Cup Cortinium is a medical device that received FDA 510(k) clearance on 2022-05-24. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K210614.

When was BENCOX Mirabo Z Cup Cortinium approved by the FDA?

BENCOX Mirabo Z Cup Cortinium received FDA 510(k) clearance on 2022-05-24, under approval number K210614.

What company makes BENCOX Mirabo Z Cup Cortinium?

BENCOX Mirabo Z Cup Cortinium is manufactured by Corentec Co., Ltd..

What is the FDA product code for BENCOX Mirabo Z Cup Cortinium?

The FDA product code for BENCOX Mirabo Z Cup Cortinium is LPH.

Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System 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

View all 21 devices →

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.

↑