FDA.reportPublic FDA data

BENCOX Hip System

Primary DI
08806373853883
Brand
BENCOX Hip System
Company
Corentec Co., Ltd
Model
H1.A11.1050
Device description
Bencox Mirabo cup (w/o Screw hole plug)
Published
2015-10-26
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150007000
K172806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150007000Modified Bencox Hip SystemCorentec Co., Ltd.2015-05-04LPH
K172806000Bencox Mirabo Cup SystemCorentec Co., Ltd.2017-10-17LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373853883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373853883088063738538838806373853883

GMDN Terms#

Term, Definition table
TermDefinition
Metallic acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.

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
08800068983558BENCOXHA.0B8.00012026-07-24
08800017271095BENCOXHA.02G.00012026-04-10
08800017269726EXULT Knee Replacement SystemK3.FAL.73762020-05-21
08800017269733EXULT Knee Replacement SystemK3.FAR.73762020-05-21
08800017269740EXULT Knee Replacement SystemK3.FAL.76782020-05-21
08800017269757EXULT Knee Replacement SystemK3.FAR.76782020-05-21
08800017269764EXULT Knee Replacement SystemK3.FBL.73762020-05-21
08800017269771EXULT Knee Replacement SystemK3.FBR.73762020-05-21
08800017269788EXULT Knee Replacement SystemK3.FBL.76782020-05-21
08800017269795EXULT Knee Replacement SystemK3.FBR.76782020-05-21
08800017260853EXULT Knee Replacement SystemK3.BFN.36572020-01-10
08800017260860EXULT Knee Replacement SystemK3.BFN.38602020-01-10
08800017260877EXULT Knee Replacement SystemK3.BFN.40632020-01-10
08800017260884EXULT Knee Replacement SystemK3.BFN.42662020-01-10
08800017260891EXULT Knee Replacement SystemK3.BFN.44692020-01-10
08800017260907EXULT Knee Replacement SystemK3.BFN.45722020-01-10
08800017260914EXULT Knee Replacement SystemK3.BFN.47752020-01-10
08800017260921EXULT Knee Replacement SystemK3.BFN.50792020-01-10
08800017260938EXULT Knee Replacement SystemK3.BFN.53832020-01-10
08800017260945EXULT Knee Replacement SystemK3.BFN.57862020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707467Z1® Hip SystemZimmer, Inc.LZO2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.KWY2026-07-29
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09