101176000

GUDID 10603295000587

PROTRUSIO CAGE CEMENTED ACETABULAR RECONSTRUCTION 60mm OD 57mm ID LEFT

DEPUY ORTHOPAEDICS, INC.

Acetabular shell

• Primary Device ID: 10603295000587
• NIH Device Record Key: 09a46332-a5e8-4199-a6c4-53572df6ef43
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1011-76-000
• Catalog Number: 101176000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295000587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962007

FDA Product Code

• JDJ: Mesh, surgical, acetabular, hip, prosthesis

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: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295061540 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 8 Inches 19.5mm 45mm OFFSET
• 10603295061557 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 8 Inches 21.0mm 45mm OFFSET
• 10603295061564 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 8 Inches 22.5mm 45mm OFFSET
• 10603295061694 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 10 Inches 21.0mm 45mm OFFSET
• 10603295061700 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 10 Inches 22.5mm 45mm OFFSET
• 10603295061724 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE RIGHT 10 Inches 15.0mm 45mm OFFSET