MiniMAX Stems

GUDID 07630030803147

Cementless anatomical stem right size 0

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030803147
• NIH Device Record Key: 64ef0c37-5ea5-4eef-9740-9b4bda9aed4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniMAX Stems
• Version Model Number: 01.13.100R
• 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	07630030803147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170845

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

On-Brand Devices [MiniMAX Stems]

• 07630030803307: Cementless anatomical stem right size 8
• 07630030803291: Cementless anatomical stem left size 8
• 07630030803284: Cementless anatomical stem right size 7
• 07630030803277: Cementless anatomical stem left size 7
• 07630030803260: Cementless anatomical stem right size 6
• 07630030803253: Cementless anatomical stem left size 6
• 07630030803246: Cementless anatomical stem right size 5
• 07630030803239: Cementless anatomical stem left size 5
• 07630030803222: Cementless anatomical stem right size 4
• 07630030803215: Cementless anatomical stem left size 4
• 07630030803208: Cementless anatomical stem right size 3
• 07630030803192: Cementless anatomical stem left size 3
• 07630030803185: Cementless anatomical stem right size 2
• 07630030803178: Cementless anatomical stem left size 2
• 07630030803161: Cementless anatomical stem right size 1
• 07630030803154: Cementless anatomical stem left size 1
• 07630030803147: Cementless anatomical stem right size 0
• 07630030803130: Cementless anatomical stem left size 0
• 07630971238800: Cementless Anatomical Stem, Right, Size 9
• 07630971238794: Cementless Anatomical Stem, Left, Size 9