Vectre

GUDID 00815361020600

5.0 mm x 25 mm Vectre Facet Screw, Fully Threaded

QUANDARY MEDICAL LLC

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00815361020600
• NIH Device Record Key: bd0396c2-7a33-452b-a665-3c0e23c4b29e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vectre
• Version Model Number: TR1-2832
• Company DUNS: 079938581
• Company Name: QUANDARY 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815361020600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073515

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Vectre]

• 00815361020679: 5.0 mm x 40 mm Vectre Facet Screw, Lag
• 00815361020662: 5.0 mm x 35 mm Vectre Facet Screw, Lag
• 00815361020655: 5.0 mm x 30 mm Vectre Facet Screw, Lag
• 00815361020648: 5.0 mm x 25 mm Vectre Facet Screw, Lag
• 00815361020631: 5.0 mm x 40 mm Vectre Facet Screw, Fully Threaded
• 00815361020624: 5.0 mm x 35 mm Vectre Facet Screw, Fully Threaded
• 00815361020617: 5.0 mm x 30 mm Vectre Facet Screw, Fully Threaded
• 00815361020600: 5.0 mm x 25 mm Vectre Facet Screw, Fully Threaded
• 00815361020594: XL Vectre Wire
• 00815361020587: Vectre System Instrumentation
• 00815361020570: Vectre Wire
• 00815361020266: Vectre Screw Set, 40 mm (2 pk) with perm washer
• 00815361020259: Vectre Screw Set, 35 mm (2 pk) with perm washer
• 00815361020242: Vectre Screw Set, 30 mm (2 pk) with perm washer
• 00815361020235: Vectre Screw Set, 25 mm (2 pk) with perm washer