Biolox Delta Modular Head 28mm MEDUM 0.0mm 12/14 E 104.2805

GUDID 05055196964327

BIOLOX Delta Ceramic Head

CORIN LTD

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 05055196964327
• NIH Device Record Key: e8315ac1-8d1b-4583-87ba-83b1759d5f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta Modular Head 28mm MEDUM 0.0mm 12/14 E
• Version Model Number: 104.2805
• Catalog Number: 104.2805
• 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: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196964327 [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

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

Radiation Sterilization

[05055196964327]

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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• 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
• 05056139209550 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L45mm
• 05056139209567 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L50mm
• 05056139209574 - MobiliT Cup: 2024-02-19 Cortical Bone screw Ø 4.5mm L55mm