4CIS VANE SPINE SYSTEM 4012-7060

GUDID 08806373568138

Poly Axial Pedicle Screw, 7.0x60mm

ALPHANOX CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806373568138
• NIH Device Record Key: 9315d9cd-e2e9-4e06-9a7c-41454e72b318
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS VANE SPINE SYSTEM
• Version Model Number: 4012-7060
• Catalog Number: 4012-7060
• Company DUNS: 687844241
• Company Name: ALPHANOX 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373568138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101818

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

[08806373568138]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-29
• Device Publish Date: 2015-09-24

On-Brand Devices [4CIS VANE SPINE SYSTEM]

• 08806373583995: Mono Extended Long Arm Pedicle Screw, Ø6.5X45mm
• 08806373583988: Mono Extended Long Arm Pedicle Screw, Ø6.5X40mm
• 08806373583971: Mono Extended Long Arm Pedicle Screw, Ø7.5X45mm
• 08806373583964: Mono Extended Long Arm Pedicle Screw, Ø7.5X40mm
• 08806373583117: Poly Extended Long Arm Pedicle Screw Ø6.5x30mm
• 08806373582158: Mono-Axial Screw Driver
• 08806373581465: Sharp Tip Straight Long Level Rod, Ø5.5x300mm
• 08806373581458: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x250mm
• 08806373581441: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x240mm
• 08806373581434: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x230mm
• 08806373581427: Sharp Tip Pre-Bent Rod, Ø5.5x95mm
• 08806373581410: Sharp Tip Pre-Bent Rod, Ø5.5x85mm
• 08806373581403: Sharp Tip Pre-Bent Rod, Ø5.5x75mm
• 08806373581397: Sharp Tip Pre-Bent Rod, Ø5.5x200mm
• 08806373581380: Sharp Tip Pre-Bent Rod, Ø5.5x190mm
• 08806373581373: Sharp Tip Pre-Bent Rod, Ø5.5x180mm
• 08806373581366: Sharp Tip Pre-Bent Rod, Ø5.5x170mm
• 08806373581359: Sharp Tip Pre-Bent Rod, Ø5.5x160mm
• 08806373581342: Sharp Tip Pre-Bent Rod, Ø5.5x150mm
• 08806373581182: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x210mm
• 08806373581175: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x180mm
• 08806373581168: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x170mm
• 08806373581151: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x220mm
• 08806373581144: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x200mm
• 08806373581137: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x190mm
• 08806373581120: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x160mm
• 08806373581113: Sharp Tip Pre-Bent Long Level Rod, Ø5.5x150mm
• 08806373581106: Sharp Tip Pre-Bent Rod, Ø5.5x130mm
• 08806373581090: Sharp Tip Pre-Bent Rod, Ø5.5x120mm
• 08806373581083: Sharp Tip Pre-Bent Rod, Ø5.5x110mm
• 08806373581076: Sharp Tip Pre-Bent Rod, Ø5.5x100mm
• 08806373581069: Sharp Tip Pre-Bent Rod, Ø5.5x90mm
• 08806373581052: Sharp Tip Pre-Bent Rod, Ø5.5x15mm
• 08806373581045: Sharp Tip Straight Long Level Rod, Ø5.5x250mm
• 08806373581038: Sharp Tip Straight Long Level Rod, Ø5.5x240mm
• 08806373581021: Sharp Tip Straight Long Level Rod, Ø5.5x230mm
• 08806373581014: Sharp Tip Straight Long Level Rod, Ø5.5x220mm
• 08806373581007: Sharp Tip Straight Long Level Rod, Ø5.5x210mm
• 08806373580994: Sharp Tip Straight Long Level Rod, Ø5.5x200mm
• 08806373580987: Sharp Tip Straight Long Level Rod, Ø5.5x190mm
• 08806373580970: Sharp Tip Straight Long Level Rod, Ø5.5x180mm
• 08806373580963: Sharp Tip Straight Long Level Rod, Ø5.5x170mm
• 08806373580956: Sharp Tip Straight Long Level Rod, Ø5.5x160mm
• 08806373580949: Sharp Tip Straight Long Level Rod, Ø5.5x150mm
• 08806373580932: Sharp Tip Pre-Bent Rod, Ø5.5x30mm
• 08806373580925: Sharp Tip Pre-Bent Rod, Ø5.5x140mm
• 08806373580918: Sharp Tip Pre-Bent Rod, Ø5.5x25mm
• 08806373580901: Sharp Tip Pre-Bent Rod, Ø5.5x20mm
• 08806373578632: Sharp Tip Pre-Bent Rod, Ø5.5x70mm
• 08806373578625: Sharp Tip Pre-Bent Rod, Ø5.5x65mm