4CIS APOLLON SPINE SYSTEM 4192-6535

GUDID 08806373523663

Poly Axial Pedicle Screw, 6.5x35mm

ALPHANOX CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806373523663
• NIH Device Record Key: 6e6b8309-28ec-4fd9-a81c-dee3a3d37025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS APOLLON SPINE SYSTEM
• Version Model Number: 4192-6535
• Catalog Number: 4192-6535
• 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	08806373523663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082453

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

Moist Heat or Steam Sterilization

[08806373523663]

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 APOLLON SPINE SYSTEM]

• 08806373577079: Mono Axial Pedicle Screw, 7.5x55mm
• 08806373577062: Mono Axial Pedicle Screw, 7.5x50mm
• 08806373577055: Mono Axial Pedicle Screw, 7.5x30mm
• 08806373577048: Mono Axial Pedicle Screw, 7.0x55mm
• 08806373577031: Mono Axial Pedicle Screw, 7.0x50mm
• 08806373577024: Mono Axial Pedicle Screw, 6.5x55mm
• 08806373577017: Mono Axial Pedicle Screw, 6.5x30mm
• 08806373576713: Spinal Pre-Bend Rod, Ø5.7x95mm
• 08806373572401: Spinal Pre-Bend Rod, Ø5.7x30mm
• 08806373555237: Spinal Pre-Bend Rod, Ø5.7x85mm
• 08806373555220: Spinal Pre-Bend Rod, Ø5.7x55mm
• 08806373555213: Spinal Pre-Bend Rod, Ø5.7x75mm
• 08806373550553: Spinal Pre-Bend Rod, Ø5.7x65mm
• 08806373550478: Spinal Pre-Bend Rod, Ø5.7x150mm
• 08806373550461: Spinal Pre-Bend Rod, Ø5.7x140mm
• 08806373550454: Spinal Pre-Bend Rod, Ø5.7x130mm
• 08806373550447: Spinal Pre-Bend Rod, Ø5.7x120mm
• 08806373550430: Poly Axial Pedicle Screw, 7.5x65mm
• 08806373550423: Poly Axial Pedicle Screw, 7.5x60mm
• 08806373550416: Poly Axial Pedicle Screw, 7.0x60mm
• 08806373550409: Poly Axial Pedicle Screw, 6.5x65mm
• 08806373550393: Poly Axial Pedicle Screw, 6.5x60mm
• 08806373549854: Spinal Pre-Bend Rod, Ø5.7x110mm
• 08806373548987: Spinal Pre-Bend Rod, Ø5.7x100mm
• 08806373545153: Spinal Pre-Bend Rod, Ø5.7x35mm
• 08806373526114: Apollon Poly Pedicle Screw Driver
• 08806373526107: Apollon Mono Pedicle Screw Driver
• 08806373524714: Spinal Pre-Bend Rod, Ø5.7x90mm
• 08806373524707: Spinal Pre-Bend Rod, Ø5.7x80mm
• 08806373524691: Spinal Pre-Bend Rod, Ø5.7x70mm
• 08806373524684: Spinal Pre-Bend Rod, Ø5.7x60mm
• 08806373524677: Spinal Pre-Bend Rod, Ø5.7x50mm
• 08806373524660: Spinal Pre-Bend Rod, Ø5.7x45mm
• 08806373524653: Spinal Pre-Bend Rod, Ø5.7x40mm
• 08806373524219: Nut Screw, Apollon Type
• 08806373523823: Poly Axial Pedicle Screw, 7.5x55mm
• 08806373523816: Poly Axial Pedicle Screw, 7.5x50mm
• 08806373523809: Poly Axial Pedicle Screw, 7.5x45mm
• 08806373523793: Poly Axial Pedicle Screw, 7.5x40mm
• 08806373523786: Poly Axial Pedicle Screw, 7.5x35mm
• 08806373523779: Poly Axial Pedicle Screw, 7.5x30mm
• 08806373523762: Poly Axial Pedicle Screw, 7.0x55mm
• 08806373523755: Poly Axial Pedicle Screw, 7.0x50mm
• 08806373523748: Poly Axial Pedicle Screw, 7.0x45mm
• 08806373523731: Poly Axial Pedicle Screw, 7.0x40mm
• 08806373523724: Poly Axial Pedicle Screw, 7.0x35mm
• 08806373523717: Poly Axial Pedicle Screw, 7.0x30mm
• 08806373523700: Poly Axial Pedicle Screw, 6.5x55mm
• 08806373523694: Poly Axial Pedicle Screw, 6.5x50mm
• 08806373523687: Poly Axial Pedicle Screw, 6.5x45mm