FuseFix Hammertoe M19-01009-S

GUDID M695M1901009S0

Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M695M1901009S0
• NIH Device Record Key: 2a3023d9-fd8a-4fc6-96dd-3c4ab9db03fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuseFix Hammertoe
• Version Model Number: M19-01009-S
• Catalog Number: M19-01009-S
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695M1901009S0 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [FuseFix Hammertoe]

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• M695M1901009S0: Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit
• M695M1901000S0: Mini Fixed AO Handle
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• M695M13S30015S0: FuseFix Solid 0° Ø3.0mm x 15mm
• M695M13S25115S0: FuseFix Solid 10° Ø2.5mm x 15mm
• M695M13S25115D0: Demo FuseFix Solid 10° Ø2.5mm x 15mm
• M695M13S25015S0: FuseFix Solid 0° Ø2.5mm x 15mm
• M695M13S25015D0: Demo FuseFix Solid 0° Ø2.5mm x 15mm
• M695M13S20113S0: FuseFix Solid 10° Ø2.0mm x 13mm
• M695M13S20013S0: FuseFix Solid 0° Ø2.0mm x 13mm
• M695M13C30015S0: FuseFix Cannulated Ø3.0mm x 15mm
• M695M13C25015S0: FuseFix Cannulated Ø2.5mm x 15mm
• M695M13C25015D0: Demo FuseFix Cannulated Ø2.5mm x 15mm
• M695M13C20013S0: FuseFix Cannulated Ø2.0mm x 13mm