Minimally Invasive Deformity Correction (MID-C) System

GUDID 07290018128145

APIFIX LTD

Spinal dynamic-stabilization system

• Primary Device ID: 07290018128145
• NIH Device Record Key: 6e98e6e2-b4da-4ea8-916c-4a7c5aa3dff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minimally Invasive Deformity Correction (MID-C) System
• Version Model Number: Screw 6.5 X 35
• Company DUNS: 649220688
• Company Name: APIFIX 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: 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	07290018128145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H170001

FDA Product Code

• QGP: Posterior Ratcheting Rod System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-10
• Device Publish Date: 2020-05-24

On-Brand Devices [Minimally Invasive Deformity Correction (MID-C) System]

• 07290018128312: LP Screw 6.5 X 40
• 07290018128404: Sterile LP Nut Leader
• 07290018128398: Sterile Extender Screw Insertion Adaptor
• 07290018128381: Extender - Lenke 1
• 07290018128374: Extender - Lenke 5
• 07290018128367: LP Screw 7.0 X 50
• 07290018128350: LP Screw 7.0 X 45
• 07290018128343: LP Screw 7.0 X 40
• 07290018128336: LP Screw 6.5 X 50
• 07290018128329: LP Screw 6.5 X 45
• 07290018128305: LP Screw 6.5 X 35
• 07290018128299: LP Screw 6.0 X 45
• 07290018128282: LP Screw 6.0 X 40
• 07290018128275: LP Screw 6.0 X 35
• 07290018128268: LP Screw 5.5 X 45
• 07290018128251: LP Screw 5.5 X 40
• 07290018128244: LP Screw 5.5 X 35
• 07290018128237: LP Screw 5.5 X 30
• 07290018128220: LP Screw 5.0 X 35
• 07290018128213: LP Screw 5.0 X 30
• 07290018128206: Screw 7.0 X 50
• 07290018128190: Screw 7.0 X 45
• 07290018128183: Screw 7.0 X 40
• 07290018128176: Screw 6.5 X 50
• 07290018128169: Screw 6.5 X 45
• 07290018128152: Screw 6.5 X 40
• 07290018128145: Screw 6.5 X 35
• 07290018128138: Screw 6.0 X 45
• 07290018128121: Screw 6.0 X 40
• 07290018128114: Screw 6.0 X 35
• 07290018128107: Screw 5.5 X 45
• 07290018128091: Screw 5.5 X 40
• 07290018128084: Screw 5.5 X 35
• 07290018128077: Screw 5.5 X 30
• 07290018128060: Screw 5.0 X 35
• 07290018128053: Screw 5.0 X 30
• 07290018128046: MID-C 125
• 07290018128039: MID-C 115
• 07290018128022: MID-C 105
• 07290018128015: MID-C 95
• 07290018128008: MID-C 85
• 07290014993808: MID-C Surgical Instruments Kit
• 07290018128411: Extender- Lenke 1 Left