4CIS® Marlin ACIF Cage SYSTEM MPU5-E12B

GUDID 08806373582349

4CIS® Marlin PEEK ACIF Cage 5, 14x12x11mm

SOLCO BIOMEDICAL CO.,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08806373582349
• NIH Device Record Key: dcc10a8e-8076-4c4a-8f7a-fde9005bede5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® Marlin ACIF Cage SYSTEM
• Version Model Number: MPU5-E12B
• Catalog Number: MPU5-E12B
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL 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	08806373582349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162402

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

[08806373582349]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-22
• Device Publish Date: 2017-08-15

On-Brand Devices [4CIS® Marlin ACIF Cage SYSTEM]

• 08806373584480: 4CIS® Marlin Cage Inserter
• 08806373583193: 4CIS® Marlin Cage Inserter
• 08806373582264: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x12mm
• 08806373582257: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x11mm
• 08806373578427: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x7mm
• 08806373578410: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x6mm
• 08806373578298: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x10mm
• 08806373578281: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x9mm
• 08806373578274: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x7mm
• 08806373578267: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x6mm
• 08806373578250: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x5mm
• 08806373578120: 4CIS® Marlin PEEK ACIF Cage 5, 14x12x7mm
• 08806373578113: 4CIS® Marlin PEEK ACIF Cage 5, 14x12x6mm
• 08806373577956: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x8mm
• 08806373577925: 4CIS® Marlin PEEK ACIF Cage 5, 14x12x8mm
• 08806373577895: 4CIS® Marlin PEEK ACIF Cage anatomical, 12x12x8mm
• 08806373577871: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x9mm
• 08806373577864: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x8mm
• 08806373577857: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x7mm
• 08806373577840: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x6mm
• 08806373577833: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x5mm
• 08806373582899: 4CIS® Marlin Ti ACIF Cage 5˚, 14x14x6mm
• 08806373582394: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x12mm
• 08806373582387: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x11mm
• 08806373582370: 4CIS® Marlin PEEK ACIF Cage 5, 14x14x12mm
• 08806373582363: 4CIS® Marlin PEEK ACIF Cage 5, 14x14x11mm
• 08806373582356: 4CIS® Marlin PEEK ACIF Cage 5, 14x12x12mm
• 08806373582349: 4CIS® Marlin PEEK ACIF Cage 5, 14x12x11mm
• 08806373582332: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x11mm
• 08806373582325: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x12mm
• 08806373582318: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x11mm
• 08806373582301: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x14x12mm
• 08806373582295: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x14x11mm
• 08806373582288: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x12mm
• 08806373582271: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x12x11mm
• 08806373581649: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x12mm
• 08806373578441: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x10mm
• 08806373578434: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x9mm
• 08806373578403: 4CIS® Marlin PEEK ACIF Cage 5, 16x14x5mm
• 08806373578397: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x10mm
• 08806373578380: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x9mm
• 08806373578373: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x7mm
• 08806373578366: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x6mm
• 08806373578359: 4CIS® Marlin PEEK ACIF Cage 5, 12x12x5mm
• 08806373578342: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x10mm
• 08806373578335: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x9mm
• 08806373578328: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x7mm
• 08806373578311: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x6mm
• 08806373578304: 4CIS® Marlin PEEK ACIF Cage anatomical, 16x14x5mm
• 08806373578243: 4CIS® Marlin PEEK ACIF Cage anatomical, 14x14x10mm