AMIStem C Femoral Stems

GUDID 07630030804250

AMIStem C Cemented Stem Standard Size 0

Medacta International SA

Uncoated hip femur prosthesis, one-piece

• Primary Device ID: 07630030804250
• NIH Device Record Key: b087e52a-ca15-4f55-9fb5-dea28efbe8bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem C Femoral Stems
• Version Model Number: 01.18.150
• 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	07630030804250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103189

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [AMIStem C Femoral Stems]

• 07630030804335: AMIStem C Cemented Stem Standard Size 8
• 07630030804328: AMIStem C Cemented Stem Standard Size 7
• 07630030804311: AMIStem C Cemented Stem Standard Size 6
• 07630030804304: AMIStem C Cemented Stem Standard Size 5
• 07630030804298: AMIStem C Cemented Stem Standard Size 4
• 07630030804281: AMIStem C Cemented Stem Standard Size 3
• 07630030804274: AMIStem C Cemented Stem Standard Size 2
• 07630030804267: AMIStem C Cemented Stem Standard Size 1
• 07630030804250: AMIStem C Cemented Stem Standard Size 0
• 07630030803864: AMIStem C Cemented Stem Lateralized Size 8
• 07630030803857: AMIStem C Cemented Stem Lateralized Size 7
• 07630030803840: AMIStem C Cemented Stem Lateralized Size 6
• 07630030803833: AMIStem C Cemented Stem Lateralized Size 5
• 07630030803826: AMIStem C Cemented Stem Lateralized Size 4
• 07630030803819: AMIStem C Cemented Stem Lateralized Size 3
• 07630030803802: AMIStem C Cemented Stem Lateralized Size 2
• 07630030803796: AMIStem C Cemented Stem Lateralized Size 1
• 07630030803789: AMIStem C Cemented Stem Lateralized Size 0
• 07630971212541: AMIStem-C Std. Cemented Femoral stem size 00