4CIS SOLAR SPINE SYSTEM 4165-5025

GUDID 08806373542183

Mono Reduction Pedicle Screw, 5.0x25mm

ALPHANOX CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806373542183
• NIH Device Record Key: de83d74e-5b85-4f77-a9ea-1d5c3534846d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS SOLAR SPINE SYSTEM
• Version Model Number: 4165-5025
• Catalog Number: 4165-5025
• 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	08806373542183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102458

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

Moist Heat or Steam Sterilization

[08806373542183]

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 SOLAR SPINE SYSTEM]

• 08806373576768: Offset Right Hook
• 08806373576751: Offset Left Hook
• 08806373576744: Right Distractor Hook
• 08806373576737: Left Distractor Hook
• 08806373576720: Small Distractor Hook
• 08806373573033: Poly Axial Pedicle Screw, 8.0x35mm
• 08806373571701: Poly Axial Pedicle Screw, 8.0x45mm
• 08806373571695: Poly Axial Pedicle Screw, 8.0x40mm
• 08806373571299: Pedicular Distractor Hook
• 08806373571282: Long Distractor Hook
• 08806373571275: Distractor Hook
• 08806373570308: Large Distractor Hook
• 08806373558146: Cross Link, Single Type, 28mm
• 08806373557170: Poly Axial Pedicle Screw, 7.5x60mm
• 08806373557163: Poly Axial Pedicle Screw, 7.5x55mm
• 08806373557156: Poly Axial Pedicle Screw, 7.5x25mm
• 08806373557132: Poly Axial Pedicle Screw, 7.0x25mm
• 08806373557118: Poly Axial Pedicle Screw, 6.5x25mm
• 08806373557095: Poly Axial Pedicle Screw, 6.0x60mm
• 08806373557071: Poly Axial Pedicle Screw, 5.5x60mm
• 08806373556869: Mono Axial Pedicle Screw, 8.5x60mm
• 08806373556852: Mono Axial Pedicle Screw, 8.5x55mm
• 08806373556845: Mono Axial Pedicle Screw, 8.5x50mm
• 08806373556838: Mono Axial Pedicle Screw, 8.5x45mm
• 08806373556821: Mono Axial Pedicle Screw, 8.5x40mm
• 08806373556814: Mono Axial Pedicle Screw, 8.5x35mm
• 08806373556807: Mono Axial Pedicle Screw, 8.5x30mm
• 08806373556791: Mono Axial Pedicle Screw, 8.5x25mm
• 08806373556777: Mono Axial Pedicle Screw, 8.0x60mm
• 08806373556760: Mono Axial Pedicle Screw, 8.0x55mm
• 08806373556753: Mono Axial Pedicle Screw, 8.0x30mm
• 08806373556746: Mono Axial Pedicle Screw, 8.0x25mm
• 08806373556722: Mono Axial Pedicle Screw, 7.5x60mm
• 08806373556715: Mono Axial Pedicle Screw, 7.5x55mm
• 08806373556708: Mono Axial Pedicle Screw, 7.5x25mm
• 08806373556685: Mono Axial Pedicle Screw, 7.0x25mm
• 08806373556661: Mono Axial Pedicle Screw, 6.5x60mm
• 08806373556654: Mono Axial Pedicle Screw, 6.5x25mm
• 08806373556630: Mono Axial Pedicle Screw, 6.0x60mm
• 08806373556623: Mono Axial Pedicle Screw, 6.0x30mm
• 08806373556616: Mono Axial Pedicle Screw, 6.0x25mm
• 08806373556593: Mono Axial Pedicle Screw, 5.5x60mm
• 08806373556586: Mono Axial Pedicle Screw, 5.5x55mm
• 08806373556562: Mono Axial Pedicle Screw, 5.0x60mm
• 08806373556555: Mono Axial Pedicle Screw, 5.0x55mm
• 08806373556548: Mono Axial Pedicle Screw, 5.0x50mm
• 08806373556531: Mono Axial Pedicle Screw, 5.0x45mm
• 08806373556517: Mono Axial Pedicle Screw, 4.5x60mm
• 08806373556500: Mono Axial Pedicle Screw, 4.5x55mm
• 08806373556494: Mono Axial Pedicle Screw, 4.5x50mm