LINK™ External Fixator CH2010

GUDID M963CH20100

Soft Silicone Cover to use with LINK™ devices to protect from damage. This model is for use with parts 20mm in length and 10mm in width, 4 Pin configuration. These parts are replacement/supplemental in case of damage to original cover provided with LINK™ device.

METRIC MEDICAL DEVICES, INC.

External orthopaedic fixation system, single-use

• Primary Device ID: M963CH20100
• NIH Device Record Key: 32eec27a-a472-4d6b-bef8-b9b69f81afbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK™ External Fixator
• Version Model Number: CH2010
• Catalog Number: CH2010
• Company DUNS: 830255506
• Company Name: METRIC MEDICAL DEVICES, INC.
• 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
HIBCC	M963CH20100 [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