FDA.reportPublic FDA data

BENCOX Hip System

Primary DI
08806373833311
Brand
BENCOX Hip System
Company
Corentec Co., Ltd
Model
01.01.903
Device description
BENCOX II STEM(Blasting)
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103431000
K120924000
K122099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103431000COREN TOTAL HIP SYSTEMCorentec Co., Ltd.2011-07-21LPH
K120924000BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUGCorentec Co., Ltd.2012-09-10LPH
K122099000BENCOX II STEM, BENCOX METAL HEADCorentec Co., Ltd.2012-10-05LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373833311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373833311088063738333118806373833311

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Contacts#

Phone, Email table
PhoneEmail
+820415857114hckoh@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017262178EXULT Knee Replacement SystemK3.IAX.4469-09T2020-01-10
08800017262185EXULT Knee Replacement SystemK3.IAX.4469-10T2020-01-10
08800017262192EXULT Knee Replacement SystemK3.IAX.4469-11T2020-01-10
08800017262208EXULT Knee Replacement SystemK3.IAX.4469-12T2020-01-10
08800017262215EXULT Knee Replacement SystemK3.IAX.4469-13T2020-01-10
08800017262222EXULT Knee Replacement SystemK3.IAX.4469-14T2020-01-10
08800017262239EXULT Knee Replacement SystemK3.IAX.4469-16T2020-01-10
08800017262246EXULT Knee Replacement SystemK3.IAX.4469-18T2020-01-10
08800017262253EXULT Knee Replacement SystemK3.IAX.4572-09T2020-01-10
08800017262260EXULT Knee Replacement SystemK3.IAX.4572-10T2020-01-10
08800017262277EXULT Knee Replacement SystemK3.IAX.4572-11T2020-01-10
08800017262284EXULT Knee Replacement SystemK3.IAX.4572-12T2020-01-10
08800017262291EXULT Knee Replacement SystemK3.IAX.4572-13T2020-01-10
08800017262307EXULT Knee Replacement SystemK3.IAX.4572-14T2020-01-10
08800017262314EXULT Knee Replacement SystemK3.IAX.4572-16T2020-01-10
08800017262321EXULT Knee Replacement SystemK3.IAX.4572-18T2020-01-10
08800017262338EXULT Knee Replacement SystemK3.IAX.4775-09T2020-01-10
08800017262345EXULT Knee Replacement SystemK3.IAX.4775-10T2020-01-10
08800017262352EXULT Knee Replacement SystemK3.IAX.4775-11T2020-01-10
08800017262369EXULT Knee Replacement SystemK3.IAX.4775-12T2020-01-10

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