AMIStem-P

GUDID 07630040720137

AMIStem-P LAT stem #4

Medacta International SA

Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630040720137
• NIH Device Record Key: ea9a4ed7-f909-4bd0-8ec6-0d096b5a14bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem-P
• Version Model Number: 01.18.414
• 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	07630040720137 [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]

• 07630040720175: AMIStem-P LAT stem #8
• 07630040720168: AMIStem-P LAT stem #7
• 07630040720151: AMIStem-P LAT stem #6
• 07630040720144: AMIStem-P LAT stem #5
• 07630040720137: AMIStem-P LAT stem #4
• 07630040720120: AMIStem-P LAT stem #3
• 07630040720113: AMIStem-P LAT stem #2
• 07630040720106: AMIStem-P LAT stem #1
• 07630040720090: AMIStem-P LAT stem #0
• 07630040720083: AMIStem-P STD stem #9
• 07630040720076: AMIStem-P STD stem #8
• 07630040720069: AMIStem-P STD stem #7
• 07630040720052: AMIStem-P STD stem #6
• 07630040720045: AMIStem-P STD stem #5
• 07630040720038: AMIStem-P STD stem #4
• 07630040720021: AMIStem-P STD stem #3
• 07630040720014: AMIStem-P STD stem #2
• 07630040720007: AMIStem-P STD stem #1
• 07630040719995: AMIStem-P STD stem #0
• 07630040719988: AMIStem-P STD stem #00