AML 155401120

GUDID 10603295058229

AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm SMALL STATURE 155mm LENGTH 40mm OFFSET

DEPUY ORTHOPAEDICS, INC.

Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular

• Primary Device ID: 10603295058229
• NIH Device Record Key: b1395bda-0ad3-4096-ba7b-fe9581c3af73
• Commercial Distribution Discontinuation: 2021-10-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AML
• Version Model Number: 1554-01-120
• Catalog Number: 155401120
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295058229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012364

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: 2021-10-18
• Device Publish Date: 2015-09-24

On-Brand Devices [AML]

• 10603295119753: AML TRIAL IMPLANT DRIVER
• 10603295058342: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm LARGE STATURE 160mm LENGTH 40mm OFFSET
• 10603295058328: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm LARGE STATURE 160mm LENGTH 40mm OFFSET
• 10603295058229: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm SMALL STATURE 155mm LENGTH 40mm OFFSET
• 10603295058205: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm SMALL STATURE 155mm LENGTH 40mm OFFSET