LINK™ External Fixator 4H201020

GUDID M9634H201020

LINK™ External Fixator, 4 Pin, Square Configuration intended for assembly and use with appropriately sized Bone Pins designed to stabilize fractured bones, osteotomies or arthrodesis to promote treatment and healing. This is a single-use device that is provided sterile. A Silicone cover is provided within the package to assist with the protection of the LINK™ structure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.

METRIC MEDICAL DEVICES, INC.

External orthopaedic fixation system, single-use

• Primary Device ID: M9634H201020
• NIH Device Record Key: 52ff1fe3-5241-4c8c-9e73-41d2491ace16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK™ External Fixator
• Version Model Number: 4H201020
• Catalog Number: 4H201020
• Company DUNS: 830255506
• Company Name: METRIC MEDICAL DEVICES, INC.
• 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

Customer Support Contacts

• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com
• Phone: 8305356300
• Email: sales@metricmd.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 76.7 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 170 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9634H201020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240049

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [LINK™ External Fixator]

• M963CH20100: Soft Silicone Cover to use with LINK™ devices to protect from damage. This model is for use w
• M963C200: Soft Silicone Cover to use with LINK™ devices to protect from damage. This model is for use w
• M9634H201020: LINK™ External Fixator, 4 Pin, Square Configuration intended for assembly and use with appropr
• M96322000200: LINK™ External Fixator, 2 Pin, Straight Configuration intended for assembly and use with appro
• M96320TT0: 2.0 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segre
• M96320TG0: 2.0 mm Diameter, Threaded and Grooved Bone Pins as part of the LINK™ External Fixator, provide
• M96316TT0: 1.6 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segre