BENCOX Hip System

GUDID 08806373834189

BENCOX forte Head

Corentec Co., Ltd

Ceramic femoral head prosthesis

• Primary Device ID: 08806373834189
• NIH Device Record Key: 33c06ac8-3c04-49c3-891f-9be4e930e095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENCOX Hip System
• Version Model Number: 01.01.251
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373834189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121665

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-16

On-Brand Devices [BENCOX Hip System]

• 08806373892677: Primary Stem Extractor
• 08806373887710: Stem Extractor
• 08806373830778: BENCOX Metal Head (Skirted type)
• 08806373830761: BENCOX Metal Head (Skirted type)
• 08806373830747: BENCOX Metal Head (Standard type)
• 08806373830730: BENCOX Metal Head (Standard type)
• 08806373830723: BENCOX Metal Head (Standard type)
• 08806373830716: BENCOX Metal Head (Standard type)
• 08806373830709: BENCOX Metal Head (Standard type)
• 08806373830693: BENCOX Metal Head (Standard type)
• 08806373830686: BENCOX Metal Head (Standard type)
• 08806373830679: BENCOX Metal Head (Standard type)
• 08806373830662: BENCOX Metal Head (Standard type)
• 08806373830655: BENCOX Metal Head (Standard type)
• 08806373830648: BENCOX Metal Head (Standard type)
• 08806373830631: BENCOX Metal Head (Standard type)
• 08806373830624: BENCOX Metal Head (Standard type)
• 08806373830617: BENCOX Metal Head (Standard type)
• 08806373830600: BENCOX Metal Head (Standard type)
• 08806373830594: BENCOX Metal Head (Standard type)
• 08806373830587: BENCOX Metal Head (Standard type)
• 08806373830570: BENCOX Metal Head (Standard type)
• 08806373830563: BENCOX Metal Head (Standard type)
• 08806373872686: Calcar reamer
• 08806373872679: Calcar reamer
• 08806373858314: BENCOX Delta
• 08806373858307: BENCOX Delta
• 08806373834509: BENCOX delta Head
• 08806373834493: BENCOX delta Head
• 08806373834486: BENCOX delta Head
• 08806373834479: BENCOX delta Head
• 08806373834462: BENCOX delta Head
• 08806373834455: BENCOX delta Head
• 08806373834448: BENCOX delta Head
• 08806373834431: BENCOX delta Head
• 08806373834424: BENCOX delta Head
• 08806373834417: BENCOX delta Head
• 08806373834400: BENCOX delta Head
• 08806373834394: BENCOX delta Head
• 08806373834387: BENCOX delta Head
• 08806373834264: BENCOX forte Head
• 08806373834257: BENCOX forte Head
• 08806373834240: BENCOX forte Head
• 08806373834233: BENCOX forte Head
• 08806373834226: BENCOX forte Head
• 08806373834219: BENCOX forte Head
• 08806373834202: BENCOX forte Head
• 08806373834196: BENCOX forte Head
• 08806373834189: BENCOX forte Head
• 08806373831300: BENCOX Bipolar Cup