136308000

GUDID 10603295032663

MODULAR CATHCART TAPERED SPACER 12/14 TAPER -3mm

DEPUY ORTHOPAEDICS, INC.

Femoral head/stem prosthesis adaptor

• Primary Device ID: 10603295032663
• NIH Device Record Key: bdfd56e6-205e-4fa2-a997-eaf62eb1d69a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1363-08-000
• Catalog Number: 136308000
• 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	10603295032663 [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.

• 10603295552628 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 1.0 mm
• 10603295552635 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 6 - 8
• 10603295552703 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 3 - 5
• 10603295552789 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 2.0 mm
• 10603295552840 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 3.0 mm
• 10603295552857 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL SO
• 10603295553465 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL HO
• 10603295553472 - ATTUNETM: 2025-08-05 ATTUNETM MAKE TO ORDER FEMORAL TRIAL SHIM 1mm THICK