TransFasten - LSF (Lateral Sacroiliac Fusion System)

GUDID M73910110450

Sacroiliac Immobilization Device - 9mm (D) x 45mm (L)

CAPTIVA SPINE, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: M73910110450
• NIH Device Record Key: dec5764d-8015-4bda-aae9-1a65377976af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransFasten - LSF (Lateral Sacroiliac Fusion System)
• Version Model Number: 10-1-1045
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M73910110450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170475

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

[M73910110450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-01

On-Brand Devices [TransFasten - LSF (Lateral Sacroiliac Fusion System)]

• M73910110650: Sacroiliac Immobilization Device - 9mm (D) x 65mm (L)
• M73910110600: Sacroiliac Immobilization Device - 9mm (D) x 60mm (L)
• M73910110550: Sacroiliac Immobilization Device - 9mm (D) x 55mm (L)
• M73910110500: Sacroiliac Immobilization Device - 9mm (D) x 50mm (L)
• M73910110450: Sacroiliac Immobilization Device - 9mm (D) x 45mm (L)
• M73910110400: Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)
• M73910110350: Sacroiliac Immobilization Device - 9mm (D) x 35mm (L)
• M73910110300: Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)
• M73910110250: Sacroiliac Immobilization Device - 9mm (D) x 25mm (L)