AMIStem H Femoral Stems

GUDID 07630030804212

AMIStem H Cementless Stem Lateralized size 5

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030804212
• NIH Device Record Key: 54589fa9-b3c9-4bfd-8c66-b2dc81ed1b62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem H Femoral Stems
• Version Model Number: 01.18.145
• 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	07630030804212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093944

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 Femoral Stems]

• 07630030804243: AMIStem H Cementless Stem Lateralized size 8
• 07630030804236: AMIStem H Cementless Stem Lateralized size 7
• 07630030804229: AMIStem H Cementless Stem Lateralized size 6
• 07630030804212: AMIStem H Cementless Stem Lateralized size 5
• 07630030804205: AMIStem H Cementless Stem Lateralized size 4
• 07630030804199: AMIStem H Cementless Stem Lateralized size 3
• 07630030804182: AMIStem H Cementless Stem Lateralized size 2
• 07630030804175: AMIStem H Cementless Stem Lateralized size 1
• 07630030804168: AMIStem H Cementless Stem Lateralized size 0
• 07630030804151: AMIStem H Cementless Stem Standard size 9
• 07630030804144: AMIStem H Cementless Stem Standard size 8
• 07630030804137: AMIStem H Cementless Stem Standard size 7
• 07630030804120: AMIStem H Cementless Stem Standard size 6
• 07630030804113: AMIStem H Cementless Stem Standard size 5
• 07630030804106: AMIStem H Cementless Stem Standard size 4
• 07630030804090: AMIStem H Cementless Stem Standard size 3
• 07630030804083: AMIStem H Cementless Stem Standard size 2
• 07630030804076: AMIStem H Cementless Stem Standard size 1
• 07630030804069: AMIStem H Cementless Stem Standard size 0
• 07630030803765: AMIStem H Cementless Stem Standard size 00