TOEGRIP® EVO TGELL10

GUDID 03701091001620

Interphalangeal device

ADSM

Interphalangeal joint arthrodesis implant

• Primary Device ID: 03701091001620
• NIH Device Record Key: 5d68e527-277e-414e-a098-eabf353b745d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOEGRIP® EVO
• Version Model Number: TGELL10
• Catalog Number: TGELL10
• Company DUNS: 266749350
• Company Name: ADSM
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com

Device Dimensions

• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree
• Device Size Text, specify: 0
• Angle: 10 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701091001620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133477

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2020-12-24
• Device Publish Date: 2020-12-16

On-Brand Devices [TOEGRIP® EVO]

• 03701091001729: Interphalangeal device
• 03701091001712: Interphalangeal device
• 03701091001705: Interphalangeal device
• 03701091001699: Interphalangeal device
• 03701091001682: Interphalangeal device
• 03701091001675: Interphalangeal device
• 03701091001668: Interphalangeal device
• 03701091001651: Interphalangeal device
• 03701091001644: Interphalangeal device
• 03701091001637: Interphalangeal device
• 03701091001620: Interphalangeal device
• 03701091001613: Interphalangeal device
• 03701091001606: Interphalangeal device
• 03701091001590: Interphalangeal device
• 03701091001583: Interphalangeal device