101105501

GUDID 10603295000365

ROOF PILE SCREW 6.5mm x 40mm

DEPUY ORTHOPAEDICS, INC.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 10603295000365
• NIH Device Record Key: 65796c3a-e72c-49f4-a9ce-0bf2e55faea1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1011-05-501
• Catalog Number: 101105501
• 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	10603295000365 [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.

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• 10603295094111 - NA: 2025-01-10 M.B.T. EVALUATION BULLET W/O PEGS SIZE 1-3
• 10603295094128 - NA: 2025-01-10 M.B.T. EVALUATION BULLET W/O PEGS SIZE 4-7
• 10603295215738 - P.F.C.: 2025-01-10 P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 2 10 DEG
• 10603295215745 - P.F.C.: 2025-01-10 P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 2 20 DEG
• 10603295215776 - P.F.C.: 2025-01-10 P.F.C. MODULAR PLUS FULL WEDGE TRIAL SZ 2 10 DEG
• 10603295215783 - P.F.C.: 2025-01-10 P.F.C. MODULAR PLUS FULL WEDGE TRIAL SZ 2 15 DEG