AMIStem-P Collared

GUDID 07630040720311

AMIStem-P Collared LAT stem #2

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630040720311
• NIH Device Record Key: 11a29042-b5f8-4af9-9631-ffbc8388f04f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem-P Collared
• Version Model Number: 01.18.442
• 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	07630040720311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173794

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [AMIStem-P Collared]

• 07630040720373: AMIStem-P Collared LAT stem #8
• 07630040720366: AMIStem-P Collared LAT stem #7
• 07630040720359: AMIStem-P Collared LAT stem #6
• 07630040720342: AMIStem-P Collared LAT stem #5
• 07630040720335: AMIStem-P Collared LAT stem #4
• 07630040720328: AMIStem-P Collared LAT stem #3
• 07630040720311: AMIStem-P Collared LAT stem #2
• 07630040720304: AMIStem-P Collared LAT stem #1
• 07630040720298: AMIStem-P Collared LAT stem #0
• 07630040720281: AMIStem-P Collared STD stem #9
• 07630040720274: AMIStem-P Collared STD stem #8
• 07630040720267: AMIStem-P Collared STD stem #7
• 07630040720250: AMIStem-P Collared STD stem #6
• 07630040720243: AMIStem-P Collared STD stem #5
• 07630040720236: AMIStem-P Collared STD stem #4
• 07630040720229: AMIStem-P Collared STD stem #3
• 07630040720212: AMIStem-P Collared STD stem #2
• 07630040720205: AMIStem-P Collared STD stem #1
• 07630040720199: AMIStem-P Collared STD stem #0
• 07630040720182: AMIStem-P Collared STD stem #00