TranS1

GUDID 00815361020525

AxiaLIF Plus 1-Level, S1 30 mm Distraction Rod

QUANDARY MEDICAL LLC

Vertebral body prosthesis

• Primary Device ID: 00815361020525
• NIH Device Record Key: d6f2a797-a17b-4463-adf1-07c8811d8129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TranS1
• Version Model Number: TR1-2379
• 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	00815361020525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102334

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-15

On-Brand Devices [TranS1]

• 00815361020563: AxiaLIF Plus 1-Level 22.5 mm L5, TS 22.5 mm Fixation Rod
• 00815361020556: AxiaLIF Plus 1-Level 20 mm L5, TS 20 mm Fixation Rod
• 00815361020549: AxiaLIF Plus 1-Level, S1 40 mm Distraction Rod
• 00815361020532: AxiaLIF Plus 1-Level, S1 35 mm Distraction Rod
• 00815361020525: AxiaLIF Plus 1-Level, S1 30 mm Distraction Rod
• 00815361020518: AxiaLIF Plus 1-Level, S1 25 mm Distraction Rod
• 00815361020501: AxiaLIF Plus 2-Level, S1 40 mm Distraction Rod
• 00815361020495: AxiaLIF Plus 2-Level, S1 35 mm Distraction Rod
• 00815361020488: AxiaLIF Plus 2-Level, S1 30 mm Distraction Rod
• 00815361020471: AxiaLIF Plus 2-Level, S1 25 mm Distraction Rod
• 00815361020464: AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 12, 65 mm Fixation Rod
• 00815361020457: AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 11, 65 mm Fixation Rod
• 00815361020440: AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 10, 65 mm Fixation Rod
• 00815361020433: AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 12, 60 mm Fixation Rod
• 00815361020426: AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 11, 60 mm Fixation Rod
• 00815361020419: AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 10, 60 mm Fixation Rod
• 00815361020402: AxiaLIF Plus 2-Level, L4-L5 55 mm 10 X 12, 55 mm Fixation Rod
• 00815361020396: AxiaLIF Plus 2-Level, L4-L5 55 mm 10 X 11, 55 mm Fixation Rod
• 00815361020389: AxiaLIF Plus 2-Level, L4-L5 55 mm 10 X 10, 55 mm Fixation Rod
• 00815361020372: AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 12, 50 mm Fixation Rod
• 00815361020365: AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 11, 50 mm Fixation Rod
• 00815361020358: AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 10, 50 mm Fixation Rod
• 00815361020341: AxiaLIF Plus Single Use Instrument Kit
• 00815361020334: AxiaLIF Plus Conformable Tip Tubular Retractor
• 00815361020327: AxiaLIF Plus Bowel Retractor Kit
• 00815361020310: AxiaLIF Plus Endplate Preparation Rasps
• 00815361020303: AxiaLIF Plus 26" Guide Wire
• 00815361020297: AxiaLIF Plus Exchange System Fixation Wire
• 00815361020280: AxiaLIF Plus Tight Disc Cutter Set
• 00815361020273: AxiaLIF Plus Tissue Extractor Set
• 00815361020228: AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 90 mm Length
• 00815361020211: AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 85 mm Length
• 00815361020204: AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 80 mm Length
• 00815361020198: AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 75 mm Length
• 00815361020181: AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 70 mm Length
• 00815361020174: AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 90 mm Length
• 00815361020167: AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 85 mm Length
• 00815361020150: AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 80 mm Length
• 00815361020143: AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 75 mm Length
• 00815361020136: AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 70 mm Length
• 00815361020129: AXiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 65 mm Length
• 00815361020112: AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 60 mm Length
• 00815361020105: AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 55 mm Length
• 00815361020099: AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 50 mm Length
• 00815361020082: AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 45 mm Length
• 00815361020075: AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 40 mm Length
• 00815361020068: AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 65 mm Length
• 00815361020051: AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 60 mm Length
• 00815361020044: AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 55 mm Length
• 00815361020037: AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 50 mm Length