TOEGRIP® EVO

GUDID 00196449035571

ToeGrip Evo Large 20°

Tyber Medical, LLC

Phalangeal joint arthrodesis implant

• Primary Device ID: 00196449035571
• NIH Device Record Key: c4cf7e02-37a1-46be-a036-81b609df0d30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOEGRIP® EVO
• Version Model Number: TGELL20
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• 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: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196449035571 [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: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [TOEGRIP® EVO]

• 00196449035694: ToeGrip Evo Extra-Small 20°
• 00196449035687: ToeGrip Evo Extra-Small 10°
• 00196449035670: ToeGrip Evo Extra-Small 0°
• 00196449035663: ToeGrip Evo Extra-Large 20°
• 00196449035656: ToeGrip Evo Extra-Large 10°
• 00196449035649: ToeGrip Evo Extra-Large 0°
• 00196449035632: ToeGrip Evo Small 20°
• 00196449035625: ToeGrip Evo Small 10°
• 00196449035618: ToeGrip Evo Small 0°
• 00196449035601: ToeGrip Evo Medium 20°
• 00196449035595: ToeGrip Evo Medium 10°
• 00196449035588: ToeGrip Evo Medium 0°
• 00196449035571: ToeGrip Evo Large 20°
• 00196449035564: ToeGrip Evo Large 10°
• 00196449035557: ToeGrip Evo Large 0°