AMIStem H Collared Femoral Stems

GUDID 07630030804625

AMIStem H Collared Cementless Stem Standard size 7

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030804625
• NIH Device Record Key: 21513746-1fc9-46b8-95d6-2c4faa90557f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem H Collared Femoral Stems
• Version Model Number: 01.18.237
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030804625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121011

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [AMIStem H Collared Femoral Stems]

• 07630030804731: AMIStem H Collared Cementless Stem Lateralized size 8
• 07630030804724: AMIStem H Collared Cementless Stem Lateralized size 7
• 07630030804717: AMIStem H Collared Cementless Stem Lateralized size 6
• 07630030804700: AMIStem H Collared Cementless Stem Lateralized size 5
• 07630030804694: AMIStem H Collared Cementless Stem Lateralized size 4
• 07630030804687: AMIStem H Collared Cementless Stem Lateralized size 3
• 07630030804670: AMIStem H Collared Cementless Stem Lateralized size 2
• 07630030804663: AMIStem H Collared Cementless Stem Lateralized size 1
• 07630030804656: AMIStem H Collared Cementless Stem Lateralized size 0
• 07630030804649: AMIStem H Collared Cementless Stem Standard size 9
• 07630030804632: AMIStem H Collared Cementless Stem Standard size 8
• 07630030804625: AMIStem H Collared Cementless Stem Standard size 7
• 07630030804618: AMIStem H Collared Cementless Stem Standard size 6
• 07630030804601: AMIStem H Collared Cementless Stem Standard size 5
• 07630030804595: AMIStem H Collared Cementless Stem Standard size 4
• 07630030804588: AMIStem H Collared Cementless Stem Standard size 3
• 07630030804571: AMIStem H Collared Cementless Stem Standard size 2
• 07630030804564: AMIStem H Collared Cementless Stem Standard size 1
• 07630030804557: AMIStem H Collared Cementless Stem Standard size 0
• 07630030804540: AMIStem H Collared Cementless Stem Standard size 00