4-Level Cervical Plates, 82 mm

GUDID M739CP300820

CAPTIVA SPINE, INC.

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: M739CP300820
• NIH Device Record Key: ae685756-c522-4adf-ac40-ca63f1ff611e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4-Level Cervical Plates, 82 mm
• Version Model Number: CP30082
• 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	M739CP300820 [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

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

Moist Heat or Steam Sterilization

[M739CP300820]

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: 2017-08-11

Devices Manufactured by CAPTIVA SPINE, INC.

• M739203000210 - 4-Hole Drill Guide: 2024-03-19 4-Hole LD Drill Guide
• M739985221229 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar
• M739985221305 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 305mm, Non-Threaded Trocar
• M739985222229 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Conical Blunt
• M73910110250 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 25mm (L)
• M73910110300 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)
• M73910110350 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 35mm (L)
• M73910110400 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)