Catamaran SI Joint Fusion System SD-002

GUDID 00850033676648

Dual Port Loader

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850033676648
• NIH Device Record Key: 746a8543-47f5-4f0c-a7db-f68daed8d0c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catamaran SI Joint Fusion System
• Version Model Number: SD-002
• Catalog Number: SD-002
• Company DUNS: 117014636
• Company Name: TENON MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
GS1	00850033676648 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

[00850033676648]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Catamaran SI Joint Fusion System ]

• 00850033676792: Drill Bit 10mm x 80mm
• 00850033676648: Dual Port Loader
• 00850033676631: Inserter