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

FDA 510(k)

COREN TOTAL HIP SYSTEM

K-Number: K103431 · 2011-07-21

ApplicantCorentec Co., Ltd.
Decision Date2011-07-21
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COREN TOTAL HIP 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 2011-07-21 under 510(k) number K103431. 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 COREN TOTAL HIP SYSTEM?

COREN TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K103431.

When did COREN TOTAL HIP SYSTEM receive FDA 510(k) clearance?

COREN TOTAL HIP SYSTEM received FDA 510(k) clearance on 2011-07-21, under 510(k) number K103431.

Who is the listed applicant for COREN TOTAL HIP 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 COREN TOTAL HIP SYSTEM?

The FDA product code for COREN TOTAL HIP SYSTEM is LPH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Corentec Co., Ltd. as applicant

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.

K250889EXULT Knee Replacement SystemK242401EXULT Knee Replacement SystemK242046EXULT Knee Replacement SystemK223828BENCOX Delta Option HeadsK223223BENCOX Mirabo Z Cup CortiniumK222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

View all 31 devices →

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.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.

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.

↑