MUTARS® trial screw for trial connecting

GUDID 04048844064433

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844064433
• NIH Device Record Key: 980a9900-e5b5-4573-8db6-b73b53d163df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® trial screw for trial connecting
• Version Model Number: 77300106
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844064433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181778

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04048844064433]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

Devices Manufactured by implantcast GmbH

• 04048844042844 - n/a: 2024-10-08 modular handle 'fast fix'
• 04048844043032 - n/a: 2024-10-08 femoral/tibial extractor
• 04048844043117 - n/a: 2024-10-08 femoral impactor short
• 04048844043261 - n/a: 2024-10-08 Osteotom size 2-6
• 04048844118020 - n/a: 2024-10-08 fixation pin 3,2mm x 32mm with stop
• 04048844140021 - n/a: 2024-10-08 adapter M8 for slap hammer
• 04048844148737 - n/a: 2024-10-08 ic-patella clamp
• 04048844151652 - n/a: 2024-10-08 fixation pin 3,2 x 52mm with stop