Tandry Locking Plate System

GUDID 04719873094608

Cortex Screw 1.5mm, 14mm, Hexalobular

MICROWARE PRECISION CO., LTD.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04719873094608
• NIH Device Record Key: 453e13b7-f1b4-4295-a319-35712187cae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandry Locking Plate System
• Version Model Number: T04-214-114
• Company DUNS: 658650833
• Company Name: MICROWARE PRECISION CO., LTD.
• 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: true
• 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: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873094608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230690

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04719873094608]

Moist Heat or Steam Sterilization

[04719873094608]

Moist Heat or Steam Sterilization

[04719873094608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [Tandry Locking Plate System]

• 04719873106226: 3.5mm Locking Distal Fibula Plate, 4 Holes, Right
• 04719873105519: 3.5mm Locking One-third Tubular Plate, 10 Holes
• 04719873105496: 3.5mm Locking One-third Tubular Plate, 8 Holes
• 04719873105472: 3.5mm Locking One-third Tubular Plate, 6 Holes
• 04719873103270: Locking Screw 3.5mm, 30mm, Hexalobular
• 04719873103263: Locking Screw 3.5mm, 28mm, Hexalobular
• 04719873103256: Locking Screw 3.5mm, 26mm, Hexalobular
• 04719873103249: Locking Screw 3.5mm, 24mm, Hexalobular
• 04719873103232: Locking Screw 3.5mm, 22mm, Hexalobular
• 04719873103225: Locking Screw 3.5mm, 20mm, Hexalobular
• 04719873103218: Locking Screw 3.5mm, 18mm, Hexalobular
• 04719873103201: Locking Screw 3.5mm, 16mm, Hexalobular
• 04719873103188: Locking Screw 3.5mm, 12mm, Hexalobular
• 04719873103171: Locking Screw 3.5mm, 10mm, Hexalobular
• 04719873103010: Locking Screw 2.4mm, 30mm, Hexalobular
• 04719873103003: Locking Screw 2.4mm, 28mm, Hexalobular
• 04719873102990: Locking Screw 2.4mm, 26mm, Hexalobular
• 04719873102983: Locking Screw 2.4mm, 24mm, Hexalobular
• 04719873102976: Locking Screw 2.4mm, 22mm, Hexalobular
• 04719873102969: Locking Screw 2.4mm, 20mm, Hexalobular
• 04719873102952: Locking Screw 2.4mm, 18mm, Hexalobular
• 04719873102945: Locking Screw 2.4mm, 16mm, Hexalobular
• 04719873102938: Locking Screw 2.4mm, 14mm, Hexalobular
• 04719873102921: Locking Screw 2.4mm, 12mm, Hexalobular
• 04719873102914: Locking Screw 2.4mm, 10mm, Hexalobular
• 04719873102778: Locking Screw 2.0mm, 18mm, Hexalobular
• 04719873102761: Locking Screw 2.0mm, 16mm, Hexalobular
• 04719873102754: Locking Screw 2.0mm, 14mm, Hexalobular
• 04719873102747: Locking Screw 2.0mm, 13mm, Hexalobular
• 04719873102730: Locking Screw 2.0mm, 12mm, Hexalobular
• 04719873102723: Locking Screw 2.0mm, 11mm, Hexalobular
• 04719873102716: Locking Screw 2.0mm, 10mm, Hexalobular
• 04719873102648: Locking Screw 1.5mm, 20mm, Hexalobular
• 04719873102631: Locking Screw 1.5mm, 18mm, Hexalobular
• 04719873102624: Locking Screw 1.5mm, 16mm, Hexalobular
• 04719873102600: Locking Screw 1.5mm, 14mm, Hexalobular
• 04719873102594: Locking Screw 1.5mm, 13mm, Hexalobular
• 04719873102587: Locking Screw 1.5mm, 12mm, Hexalobular
• 04719873102570: Locking Screw 1.5mm, 11mm, Hexalobular
• 04719873102563: Locking Screw 1.5mm, 10mm, Hexalobular
• 04719873102556: Locking Screw 1.5mm, 9mm, Hexalobular
• 04719873102549: Locking Screw 1.5mm, 8mm, Hexalobular
• 04719873102532: Locking Screw 1.5mm, 7mm, Hexalobular
• 04719873102525: Locking Screw 1.5mm, 6mm, Hexalobular
• 04719873098644: 3.5mm Locking Superior Clavicle Plate, 8 Holes, Left
• 04719873098637: 3.5mm Locking Superior Clavicle Plate, 8 Holes, Right
• 04719873098620: 3.5mm Locking Superior Clavicle Plate, 7 Holes, Left
• 04719873098613: 3.5mm Locking Superior Clavicle Plate, 7 Holes, Right
• 04719873098606: 3.5mm Locking Superior Clavicle Plate, 6 Holes, Left
• 04719873098576: 1.5mm Locking T Plate, 11 Holes