C3® ACPS

GUDID 03663136001746

4.0 mm x 12 mm dual purpose screw

SPINEVISION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03663136001746
• NIH Device Record Key: 1955d37e-f820-464b-b2ec-3b05644d2d35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C3® ACPS
• Version Model Number: C1-C4012
• Company DUNS: 390377518
• Company Name: SPINEVISION
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136001746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012881

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

[03663136001746]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-12-20
• Device Publish Date: 2015-10-15

On-Brand Devices [C3® ACPS]

• 03663136002415: 4.0 mm x 20 mm variable angle screw
• 03663136001906: 31.5 mm plate with SLS
• 03663136001746: 4.0 mm x 12 mm dual purpose screw