MIS Curved Rod, Ø5.5 x 85mm

GUDID M739161554085

MIS Curved Rod

CAPTIVA SPINE, INC.

Orthopaedic instrument surgical connector

• Primary Device ID: M739161554085
• NIH Device Record Key: b82704e8-a83c-441b-b486-0e5846cfcfd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Curved Rod, Ø5.5 x 85mm
• Version Model Number: 16155-4085
• 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	M739161554085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122332

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

[M739161554085]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

Devices Manufactured by CAPTIVA SPINE, INC.

• M739161554030 - MIS Curved Rod, Ø5.5 x 30mm: 2025-05-28 MIS Curved Rod
• M739161554035 - MIS Curved Rod, Ø5.5 x 35mm: 2025-05-28 MIS Curved Rod
• M739161554040 - MIS Curved Rod, Ø5.5 x 40mm: 2025-05-28 MIS Curved Rod
• M739161554045 - MIS Curved Rod, Ø5.5 x 45mm: 2025-05-28 MIS Curved Rod
• M739161554050 - MIS Curved Rod, Ø5.5 x 50mm: 2025-05-28 MIS Curved Rod
• M739161554055 - MIS Curved Rod, Ø5.5 x 55mm: 2025-05-28 MIS Curved Rod
• M739161554060 - MIS Curved Rod, Ø5.5 x 60mm: 2025-05-28 MIS Curved Rod
• M739161554065 - MIS Curved Rod, Ø5.5 x 65mm: 2025-05-28 MIS Curved Rod