FuseFix Hammertoe M13-S25115-S

GUDID M695M13S25115S0

FuseFix Solid 10° Ø2.5mm x 15mm

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: M695M13S25115S0
• NIH Device Record Key: 1e71841d-28e4-4da1-9999-5aec6dc9e0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuseFix Hammertoe
• Version Model Number: M13-S25115-S
• Catalog Number: M13-S25115-S
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695M13S25115S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170571

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-17
• Device Publish Date: 2019-08-23

On-Brand Devices [FuseFix Hammertoe]

• M695M1901011S0: Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6”) Kit
• M695M1901009S0: Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit
• M695M1901000S0: Mini Fixed AO Handle
• M695M13S30115S0: FuseFix Solid 10° Ø3.0mm x 15mm
• 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