101401500

GUDID 10603295001232

BANTAM FEMORAL HEAD Diameter 22.225mm +0 10/12 TAPER

DEPUY ORTHOPAEDICS, INC.

Metallic femoral head prosthesis

• Primary Device ID: 10603295001232
• NIH Device Record Key: 1e4b4a90-2a6c-475b-b857-4b04c711364d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1014-01-500
• Catalog Number: 101401500
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295001232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883460

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: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295552765 - SUMMIT: 2025-05-08 SUMMIT MAKE TO ORDER LATERAL OFFSET ANT APPROACH BROACH HANDLE LEFT
• 10603295552734 - ATTUNE: 2025-05-05 ATTUNE MAKE TO ORDER 3 HOLE EXTERNAL ROTATION GUIDE Assembly
• 10603295548997 - SIGMA: 2025-04-10 SIGMA MAKE TO ORDER HP 5 DEGREE TIBIAL CUTTING BLOCK RIGHT
• 10603295549031 - SIGMA: 2025-04-10 SIGMA MAKE TO ORDER HP 5 DEGREE TIBIAL CUTTING BLOCK LEFT
• 10603295552673 - ATTUNE: 2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 29mm
• 10603295552697 - ATTUNE: 2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 41mm
• 10603295552710 - ATTUNE: 2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 32mm