Biolox Delta Modular Head 36mm MEDIUM 0.0mm 12/14 104.3605

GUDID 05055196964389

BIOLOX Delta Ceramic Head

CORIN LTD

Ceramic femoral head prosthesis

• Primary Device ID: 05055196964389
• NIH Device Record Key: 462d0401-b54b-42de-9a48-7c5ce7526d88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta Modular Head 36mm MEDIUM 0.0mm 12/14
• Version Model Number: 104.3605
• Catalog Number: 104.3605
• 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	05055196964389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110087

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

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

Radiation Sterilization

[05055196964389]

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

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• 05056139245152 - Apollo Knee: 2024-12-26 G-Array
• 05056139245169 - Apollo Knee: 2024-12-26 P-Array
• 05056139245701 - Apollo Knee: 2024-12-26 Femoral Sawing Guide
• 05056139245725 - Apollo Knee: 2024-12-26 Tibial Cutting Guide - Left
• 05056139245732 - Apollo Knee: 2024-12-26 Tibial Cutting Guide - Right