Fuse ACP F8014-0348

GUDID 08800033351559

Fuse-ACP Anterior Cervical Plate 3Level 48mm

SOLCO BIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800033351559
• NIH Device Record Key: 52626e60-72d1-405e-8e0e-83dd05499f99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fuse ACP
• Version Model Number: F8014-0348
• Catalog Number: F8014-0348
• 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	08800033351559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182489

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

[08800033351559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-24

On-Brand Devices [Fuse ACP]

• 08800033352679: Fuse-ACP Variable Self Tapping Screw ø4.35 X 16mm
• 08800033352655: Fuse-ACP Variable Self Tapping Screw ø4.35 X 14mm
• 08800033352631: Fuse-ACP Variable Self Tapping Screw ø4.35 X 12mm
• 08800033352556: Fuse-ACP Variable Self Tapping Screw ø4.0 X 16mm
• 08800033352532: Fuse-ACP Variable Self Tapping Screw ø4.0 X 14mm
• 08800033352518: Fuse-ACP Variable Self Tapping Screw ø4.0 X 12mm
• 08800033352433: Fuse-ACP Variable Self Drilling Screw ø4.35 X 16mm
• 08800033352419: Fuse-ACP Variable Self Drilling Screw ø4.35 X 14mm
• 08800033352396: Fuse-ACP Variable Self Drilling Screw ø4.35 X 12mm
• 08800033352310: Fuse-ACP Variable Self Drilling Screw ø4.0 X 16mm
• 08800033352297: Fuse-ACP Variable Self Drilling Screw ø4.0 X 14mm
• 08800033352273: Fuse-ACP Variable Self Drilling Screw ø4.0 X 12mm
• 08800033352198: Fuse-ACP Fixed Self Tapping Screw ø4.35 X 16mm
• 08800033352174: Fuse-ACP Fixed Self Tapping Screw ø4.35 X 14mm
• 08800033352150: Fuse-ACP Fixed Self Tapping Screw ø4.35 X 12mm
• 08800033352075: Fuse-ACP Fixed Self Tapping Screw ø4.0 X 16mm
• 08800033352051: Fuse-ACP Fixed Self Tapping Screw ø4.0 X 14mm
• 08800033352037: Fuse-ACP Fixed Self Tapping Screw ø4.0 X 12mm
• 08800033351955: Fuse-ACP Fixed Self Drilling Screw ø4.35 X 16mm
• 08800033351931: Fuse-ACP Fixed Self Drilling Screw ø4.35 X 14mm
• 08800033351917: Fuse-ACP Fixed Self Drilling Screw ø4.35 X 12mm
• 08800033351832: Fuse-ACP Fixed Self Drilling Screw ø4.0 X 16mm
• 08800033351818: Fuse-ACP Fixed Self Drilling Screw ø4.0 X 14mm
• 08800033351795: Fuse-ACP Fixed Self Drilling Screw ø4.0 X 12mm
• 08800033351764: Fuse-ACP Anterior Cervical Plate 5Level 91mm
• 08800033351757: Fuse-ACP Anterior Cervical Plate 5Level 86mm
• 08800033351740: Fuse-ACP Anterior Cervical Plate 5Level 81mm
• 08800033351733: Fuse-ACP Anterior Cervical Plate 5Level 76mm
• 08800033351726: Fuse-ACP Anterior Cervical Plate 5Level 71mm
• 08800033351719: Fuse-ACP Anterior Cervical Plate 4Level 78mm
• 08800033351702: Fuse-ACP Anterior Cervical Plate 4Level 74mm
• 08800033351696: Fuse-ACP Anterior Cervical Plate 4Level 70mm
• 08800033351689: Fuse-ACP Anterior Cervical Plate 4Level 66mm
• 08800033351672: Fuse-ACP Anterior Cervical Plate 4Level 62mm
• 08800033351665: Fuse-ACP Anterior Cervical Plate 4Level 58mm
• 08800033351658: Fuse-ACP Anterior Cervical Plate 4Level 54mm
• 08800033351641: Fuse-ACP Anterior Cervical Plate 4Level 50mm
• 08800033351634: Fuse-ACP Anterior Cervical Plate 4Level 46mm
• 08800033351603: Fuse-ACP Anterior Cervical Plate 3Level 63mm
• 08800033351597: Fuse-ACP Anterior Cervical Plate 3Level 60mm
• 08800033351580: Fuse-ACP Anterior Cervical Plate 3Level 57mm
• 08800033351573: Fuse-ACP Anterior Cervical Plate 3Level 54mm
• 08800033351566: Fuse-ACP Anterior Cervical Plate 3Level 51mm
• 08800033351559: Fuse-ACP Anterior Cervical Plate 3Level 48mm
• 08800033351542: Fuse-ACP Anterior Cervical Plate 3Level 45mm
• 08800033351481: Fuse-ACP Anterior Cervical Plate 2Level 42mm
• 08800033351474: Fuse-ACP Anterior Cervical Plate 2Level 40mm
• 08800033351467: Fuse-ACP Anterior Cervical Plate 2Level 38mm
• 08800033351450: Fuse-ACP Anterior Cervical Plate 2Level 36mm
• 08800033351443: Fuse-ACP Anterior Cervical Plate 2Level 34mm