546014000

GUDID 10603295174349

CEMENT RESTRICTOR SIZE 3 13.25mm

DEPUY ORTHOPAEDICS, INC.

Polymer orthopaedic cement restrictor, non-bioabsorbable

• Primary Device ID: 10603295174349
• NIH Device Record Key: c25bfebb-4167-4c26-9c48-89ac9b2b7afe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5460-14-000
• Catalog Number: 546014000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295174349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800894

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-02-05
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295013266 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 44mm OD
• 10603295013389 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 68mm OD
• 10603295013396 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 70mm OD
• 10603295013402 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 72mm OD
• 10603295013419 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 74mm OD
• 10603295013426 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER NEUTRAL 28mm ID 76mm OD
• 10603295013433 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28mm ID 44mm OD
• 10603295013556 - PINNACLE: 2024-09-26 PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28mm ID 68mm OD