AMIStem-H Proximal Coating

GUDID 07630030804359

AMIStem-H Proximal Coating STD stem #0

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030804359
• NIH Device Record Key: c2e2f3e4-507b-43de-a361-57df156e4250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem-H Proximal Coating
• Version Model Number: 01.18.170
• 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	07630030804359 [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-H Proximal Coating]

• 07630030804458: AMIStem-H Proximal Coating LAT stem #0
• 07630030804359: AMIStem-H Proximal Coating STD stem #0
• 07630030804342: AMIStem-H Proximal Coating STD stem #00