Biolox Delta Modular Head 28mm LONG +3.5mm 12/14 E 104.2810

GUDID 05055196964334

BIOLOX Delta Ceramic Head

CORIN LTD

Ceramic femoral head prosthesis

• Primary Device ID: 05055196964334
• NIH Device Record Key: 32209883-1cf8-411f-ae53-1ff5530ef902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta Modular Head 28mm LONG +3.5mm 12/14 E
• Version Model Number: 104.2810
• Catalog Number: 104.2810
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• 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: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com
• Phone: +441285659866
• Email: rachel.king@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196964334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103120

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

[05055196964334]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

Devices Manufactured by CORIN LTD

• 05055196947399 - Corin Bipolar Prosthesis: 2024-09-11 Bipolar Head Extractor
• 05056139223150 - MobiliT Cup: 2024-09-11 Clamp for trial liner
• 05056139223211 - MobiliT Cup: 2024-09-11 Liner extractor
• 05056139209468 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L20mm
• 05056139209482 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L25mm
• 05056139209499 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L30mm
• 05056139209512 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L35mm
• 05056139209536 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L40mm