101104501

GUDID 10603295000358

ROOF PILE SCREW 6.5mm x 35mm

DEPUY ORTHOPAEDICS, INC.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 10603295000358
• NIH Device Record Key: 5f32ac11-1f7e-4c6a-9fc2-f718aaa53bb3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1011-04-501
• Catalog Number: 101104501
• 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
• 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	10603295000358 [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: 2023-10-27
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295061519 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 8 Inches 15.0mm 45mm OFFSET
• 10603295061533 - SOLUTION SYSTEM: 2024-12-20 SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 8 Inches 18.0mm 45mm OFFSET
• 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