Variable Screw, Self-Tapping, 4.0mm x 12mm

GUDID M739131064012

Variable Screw, Self-Tapping, 4.0mm x 12mm

CAPTIVA SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M739131064012
• NIH Device Record Key: ff37d3d3-c833-4b33-82ec-18d6fbbca23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Screw, Self-Tapping, 4.0mm x 12mm
• Version Model Number: 13106-4012
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, INC.
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M739131064012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141332

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

[M739131064012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-10-30

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