AMIStem-P Short Neck

GUDID 07630971243750

AMIStem- P Short Neck LAT stem #1

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630971243750
• NIH Device Record Key: 67c5bf2d-1d50-48db-810d-f5844a7f1ed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMIStem-P Short Neck
• Version Model Number: 01.18.471
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	07630971243750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192126

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 2020-02-06
• Device Publish Date: 2020-01-29

On-Brand Devices [AMIStem-P Short Neck ]

• 07630971243828: AMIStem- P Short Neck LAT stem #8
• 07630971243811: AMIStem- P Short Neck LAT stem #7
• 07630971243804: AMIStem- P Short Neck LAT stem #6
• 07630971243798: AMIStem- P Short Neck LAT stem #5
• 07630971243781: AMIStem- P Short Neck LAT stem #4
• 07630971243774: AMIStem- P Short Neck LAT stem #3
• 07630971243767: AMIStem- P Short Neck LAT stem #2
• 07630971243750: AMIStem- P Short Neck LAT stem #1
• 07630971243743: AMIStem- P Short Neck LAT stem #0
• 07630971243736: AMIStem-P Short Neck STD stem #9
• 07630971243729: AMIStem-P Short Neck STD stem #8
• 07630971243712: AMIStem-P Short Neck STD stem #7
• 07630971243705: AMIStem-P Short Neck STD stem #6
• 07630971243699: AMIStem-P Short Neck STD stem #5
• 07630971243682: AMIStem-P Short Neck STD stem #4
• 07630971243675: AMIStem-P Short Neck STD stem #3
• 07630971243668: AMIStem-P Short Neck STD stem #2
• 07630971243651: AMIStem-P Short Neck STD stem #1
• 07630971243644: AMIStem-P Short Neck STD stem #0
• 07630971243637: AMIStem-P Short Neck STD stem #00