Curved Rod, 5.5 x 130 mm

GUDID M739245521300

Curved Rod, 5.5 x 190 mm Straight Rod, 5.5 x 130 mm

CAPTIVA SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M739245521300
• NIH Device Record Key: 94813fe5-6a0c-4e2a-9a7d-e1c6a6927b80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Rod, 5.5 x 130 mm
• Version Model Number: 2455-2130
• 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	M739245521300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120292

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[M739245521300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

Devices Manufactured by CAPTIVA SPINE, INC.

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• 00850065741048 - EquiLOX Lumbar Expandable Cage - Hammer connecting shaft: 2024-07-24 Hammer connecting shaft
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