FDA.reportPublic FDA data

BENCOX Hip System

Primary DI
08806373891571
Brand
BENCOX Hip System
Company
Corentec Co., Ltd
Model
HA.022.0070
Device description
Shell trial 70mm (6window)
Published
2018-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150007000Modified Bencox Hip SystemCorentec Co., Ltd.2015-05-04LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373891571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373891571088063738915718806373891571

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017271088BENCOXHA.02F.00012026-05-06
08800017261294EXULT Knee Replacement SystemK3.IAN.4266-09T2020-01-10
08800017261300EXULT Knee Replacement SystemK3.IAN.4266-10T2020-01-10
08800017261317EXULT Knee Replacement SystemK3.IAN.4266-11T2020-01-10
08800017261324EXULT Knee Replacement SystemK3.IAN.4266-12T2020-01-10
08800017261331EXULT Knee Replacement SystemK3.IAN.4266-13T2020-01-10
08800017261348EXULT Knee Replacement SystemK3.IAN.4266-14T2020-01-10
08800017261355EXULT Knee Replacement SystemK3.IAN.4266-16T2020-01-10
08800017261362EXULT Knee Replacement SystemK3.IAN.4266-18T2020-01-10
08800017261379EXULT Knee Replacement SystemK3.IAN.4469-09T2020-01-10
08800017261386EXULT Knee Replacement SystemK3.IAN.4469-10T2020-01-10
08800017261393EXULT Knee Replacement SystemK3.IAN.4469-11T2020-01-10
08800017261409EXULT Knee Replacement SystemK3.IAN.4469-12T2020-01-10
08800017261416EXULT Knee Replacement SystemK3.IAN.4469-13T2020-01-10
08800017261423EXULT Knee Replacement SystemK3.IAN.4469-14T2020-01-10
08800017261430EXULT Knee Replacement SystemK3.IAN.4469-16T2020-01-10
08800017261447EXULT Knee Replacement SystemK3.IAN.4469-18T2020-01-10
08800017261454EXULT Knee Replacement SystemK3.IAN.4572-09T2020-01-10
08800017261461EXULT Knee Replacement SystemK3.IAN.4572-10T2020-01-10
08800017261478EXULT Knee Replacement SystemK3.IAN.4572-11T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01