Catamaran SE SI Joint Fusion System 40430

GUDID 00850033676662

LP Drill Guide 7.5mm

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850033676662
• NIH Device Record Key: 779f44fe-2f95-431a-b38b-1b9440f45b80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catamaran SE SI Joint Fusion System
• Version Model Number: 40430
• Catalog Number: 40430
• 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	00850033676662 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850033676662]

Moist Heat or Steam Sterilization

[00850033676662]

Moist Heat or Steam Sterilization

[00850033676662]

Moist Heat or Steam Sterilization

[00850033676662]

Moist Heat or Steam Sterilization

[00850033676662]

Moist Heat or Steam Sterilization

[00850033676662]

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 SE SI Joint Fusion System ]

• 00850033676785: Intraoperative Extraction Tool 10mm
• 00850033676778: Graft Inserter 10mm
• 00850033676761: Dual Port Loader 10mm
• 00850033676754: Catamaran SE Sterilization Tray
• 00850033676747: Sterilization Container 7.5mm
• 00850033676730: K-Wire Driver
• 00850033676723: Intraoperative Extraction Tool
• 00850033676716: Dual Port Loader 7.5mm
• 00850033676709: LP Inserter 7.5mm
• 00850033676693: Hex Key 4 mm
• 00850033676686: Guidewire Graduated
• 00850033676679: Temporary Pin 7.5mm
• 00850033676662: LP Drill Guide 7.5mm
• 00850033676655: LP Access Sleeve 7.5mm