Volt™ Wrist Treatment System 02.426.631

GUDID 00196449018703

2.4/2.7 2Column Dist Radius Plate 6Head/3Shaft/Left/Std/55mm

Tyber Medical LLC

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00196449018703
• NIH Device Record Key: 38bc4f5d-e7b5-4f99-ab85-f65ec096a8c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volt™ Wrist Treatment System
• Version Model Number: 02.426.631
• Catalog Number: 02.426.631
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196449018703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232693

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Volt™ Wrist Treatment System]

• 00196449023820: 2.0/2.4/2.7mm VOLT™ Compact Wrist Plate Tray
• 00196449023318: Guide Block f/2Column Distal Radius Plate/Right/Wide
• 00196449023301: Guide Block f/2Column Distal Radius Plate/Left/Wide
• 00196449023295: Guide Block f/2Column Distal Radius Plate/Right/Standard
• 00196449023288: Guide Block f/2Column Distal Radius Plate/Left/Standard
• 00196449023271: Guide Block f/2Column Distal Radius Plate/Right/Narrow
• 00196449023264: Guide Block f/2Column Distal Radius Plate/Left/Narrow
• 00196449023257: Attachment Screw f/2Column Distal Radius Plate Guide Block
• 00196449023240: 2.4/2.7mm Depth Gauge/Range 0-40mm
• 00196449019090: 2.4/2.7 Vlr Rim Dist Radius Plate 7Head/3Shft/Right/Wde/62mm
• 00196449019083: 2.4/2.7 Vlr Rim Dist Radius Plate 7Head/3Shaft/Left/Wde/62mm
• 00196449019052: 2.4/2.7 Vlr Rim Dist Radius Plate 6Head/3Shft/Right/Std/60mm
• 00196449019045: 2.4/2.7 Vlr Rim Dist Radius Plate 6Head/3Shaft/Left/Std/60mm
• 00196449019014: 2.4/2.7 Vlr Rim Dist Radius Plate 6Head/3Shft/Right/Nrw/58mm
• 00196449019007: 2.4/2.7 Vlr Rim Dist Radius Plate 6Head/3Shaft/Left/Nrw/58mm
• 00196449018918: 2.4/2.7 2Column Dist Radius Plate 7Head/5Shft/Right/Wde/79mm
• 00196449018901: 2.4/2.7 2Column Dist Radius Plate 7Head/5Shaft/Left/Wde/79mm
• 00196449018895: 2.4/2.7 2Column Dist Radius Plate 7Head/4Shft/Right/Wde/70mm
• 00196449018888: 2.4/2.7 2Column Dist Radius Plate 7Head/4Shaft/Left/Wde/70mm
• 00196449018871: 2.4/2.7 2Column Dist Radius Plate 7Head/3Shft/Right/Wde/56mm
• 00196449018864: 2.4/2.7 2Column Dist Radius Plate 7Head/3Shaft/Left/Wde/56mm
• 00196449018758: 2.4/2.7 2Column Dist Radius Plate 6Head/5Shft/Right/Std/77mm
• 00196449018741: 2.4/2.7 2Column Dist Radius Plate 6Head/5Shaft/Left/Std/77mm
• 00196449018734: 2.4/2.7 2Column Dist Radius Plate 6Head/4Shft/Right/Std/70mm
• 00196449018727: 2.4/2.7 2Column Dist Radius Plate 6Head/4Shaft/Left/Std/70mm
• 00196449018710: 2.4/2.7 2Column Dist Radius Plate 6Head/3Shft/Right/Std/55mm
• 00196449018703: 2.4/2.7 2Column Dist Radius Plate 6Head/3Shaft/Left/Std/55mm
• 00196449018598: 2.4/2.7 2Column Dist Radius Plate 6Head/5Shft/Right/Nrw/76mm
• 00196449018581: 2.4/2.7 2Column Dist Radius Plate 6Head/5Shaft/Left/Nrw/76mm
• 00196449018574: 2.4/2.7 2Column Dist Radius Plate 6Head/4Shft/Right/Nrw/69mm
• 00196449018567: 2.4/2.7 2Column Dist Radius Plate 6Head/4Shaft/Left/Nrw/69mm
• 00196449018550: 2.4/2.7 2Column Dist Radius Plate 6Head/3Shft/Right/Nrw/53mm
• 00196449018543: 2.4/2.7 2Column Dist Radius Plate 6Head/3Shaft/Left/Nrw/53mm