AML 155401105

GUDID 10603295058205

AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm SMALL STATURE 155mm LENGTH 40mm OFFSET

DEPUY ORTHOPAEDICS, INC.

Coated femoral stem prosthesis, modular

• Primary Device ID: 10603295058205
• NIH Device Record Key: 6550295b-8e03-46a8-bd50-7d7adf1b7da6
• Commercial Distribution Discontinuation: 2021-10-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AML
• Version Model Number: 1554-01-105
• Catalog Number: 155401105
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295058205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012364

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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
• 10603295058502: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm LARGE STATURE HIGH OFFSET 155mm LENGTH 52mm OFFSE
• 10603295058496: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm LARGE STATURE HIGH OFFSET 155mm LENGTH 52mm OFFSE
• 10603295058489: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE
• 10603295058472: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE
• 10603295058465: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE
• 10603295058458: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE
• 10603295058441: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSE
• 10603295058427: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm LARGE STATURE 155mm LENGTH 45mm OFFSET
• 10603295058410: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm LARGE STATURE 155mm LENGTH 45mm OFFSET
• 10603295058403: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm LARGE STATURE 155mm LENGTH 45mm OFFSET
• 10603295058397: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm LARGE STATURE 155mm LENGTH 45mm OFFSET
• 10603295058380: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm LARGE STATURE 160mm LENGTH 45mm OFFSET
• 10603295058373: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm LARGE STATURE 160mm LENGTH 45mm OFFSET
• 10603295058366: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm LARGE STATURE 160mm LENGTH 45mm OFFSET
• 10603295058359: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm 6 Inches LARGE STATURE 160mm LENGTH 40mm OFFSET
• 10603295058335: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm 6 Inches LARGE STATURE 160mm LENGTH 40mm OFFSET
• 10603295058304: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET
• 10603295058298: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET
• 10603295058281: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 19.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET
• 10603295058274: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET
• 10603295058267: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 16.5mm SMALL STATURE 150mm LENGTH 43mm OFFSET
• 10603295058250: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 15.0mm SMALL STATURE 155mm LENGTH 43mm OFFSET
• 10603295058243: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm SMALL STATURE 155mm LENGTH 43mm OFFSET
• 10603295058236: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 12.0mm 6 Inches SMALL STATURE 155mm LENGTH 40mm OFFSET
• 10603295058212: AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm 6 Inches SMALL STATURE 155mm LENGTH 40mm OFFSET