FDA.reportPublic FDA data

BENCOX Bipolar Cup System

Primary DI
08806373869310
Brand
BENCOX Bipolar Cup System
Company
Corentec Co., Ltd
Model
H2.A51.0040-01
Device description
BENCOX Bipolar Cup 40mm-Insert
Published
2020-04-09
Public version status
New
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
K112019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112019000BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUPCorentec Co., Ltd.2011-10-12KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373869310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373869310088063738693108806373869310

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82415857114sungwon.yang@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
08800017261850EXULT Knee Replacement SystemK3.IAX.3657-09T2020-01-09
08800017261867EXULT Knee Replacement SystemK3.IAX.3657-10T2020-01-09
08800017261874EXULT Knee Replacement SystemK3.IAX.3657-11T2020-01-09
08800017261881EXULT Knee Replacement SystemK3.IAX.3657-12T2020-01-09
08800017261898EXULT Knee Replacement SystemK3.IAX.3657-13T2020-01-09
08800017261904EXULT Knee Replacement SystemK3.IAX.3657-14T2020-01-09
08800017261911EXULT Knee Replacement SystemK3.IAX.3657-16T2020-01-09
08800017261928EXULT Knee Replacement SystemK3.IAX.3657-18T2020-01-09
08800017267494EXULT Knee Replacement SystemK3.IAX.3657-20T2020-01-09
08800017267500EXULT Knee Replacement SystemK3.IAX.3657-22T2020-01-09
08800017267517EXULT Knee Replacement SystemK3.IAX.3657-24T2020-01-09
08800017262925EXULT Knee Replacement SystemK3.IBN.4266-12T2020-01-10
08800017262932EXULT Knee Replacement SystemK3.IBN.4266-13T2020-01-10
08800017262949EXULT Knee Replacement SystemK3.IBN.4266-14T2020-01-10
08800017262956EXULT Knee Replacement SystemK3.IBN.4266-16T2020-01-10
08800017262963EXULT Knee Replacement SystemK3.IBN.4266-18T2020-01-10
08800017262970EXULT Knee Replacement SystemK3.IBN.4469-09T2020-01-10
08800017262987EXULT Knee Replacement SystemK3.IBN.4469-10T2020-01-10
08800017262994EXULT Knee Replacement SystemK3.IBN.4469-11T2020-01-10
08800017263007EXULT Knee Replacement SystemK3.IBN.4469-12T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850116Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26