136310000

GUDID 10603295032670

MODULAR CATHCART TAPERED SPACER 12/14 TAPER +0mm

DEPUY ORTHOPAEDICS, INC.

Femoral head/stem prosthesis adaptor

• Primary Device ID: 10603295032670
• NIH Device Record Key: bdae9fc0-16e1-4d3e-9573-ad3ff1d1b03a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1363-10-000
• Catalog Number: 136310000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295032670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903084

FDA Product Code

• LZY: Prosthesis, hip, hemi-, femoral, metal ball

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: 2024-09-30
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295103585 - GLOBAL STEPTECH APG: 2025-07-17 GLOBAL STEPTECH APG BONE PREP ASSESSMENT DISK SIZE 44 +7mm
• 10603295103608 - GLOBAL STEPTECH APG: 2025-07-17 GLOBAL STEPTECH APG BONE PREP ASSESSMENT DISK SIZE 48 +5mm
• 10603295103622 - GLOBAL STEPTECH APG: 2025-07-17 GLOBAL STEPTECH APG BONE PREP ASSESSMENT DISK SIZE 52 +3mm
• 10603295103646 - GLOBAL STEPTECH APG: 2025-07-17 GLOBAL STEPTECH APG BONE PREP ASSESSMENT DISK SIZE 52 +7mm
• 10603295103660 - GLOBAL STEPTECH APG: 2025-07-17 GLOBAL STEPTECH APG BONE PREP ASSESSMENT DISK SIZE 56 +5mm
• 10603295105008 - GLOBAL CAP: 2025-07-17 GLOBAL CAP HUMERAL HEAD SHAPER 40mm x 15mm