CATAMARAN SE SIJ Fusion System CS031

GUDID 00850033676570

Sterilization Tray Assembly, Catamaran SE

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850033676570
• NIH Device Record Key: dd085d54-5781-473c-87af-d02439db06c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATAMARAN SE SIJ Fusion System
• Version Model Number: CS031
• Catalog Number: CS031
• 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	00850033676570 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850033676570]

Moist Heat or Steam Sterilization

[00850033676570]

Moist Heat or Steam Sterilization

[00850033676570]

Moist Heat or Steam Sterilization

[00850033676570]

Moist Heat or Steam Sterilization

[00850033676570]

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

Devices Manufactured by TENON MEDICAL, INC.

• 00850033676570 - CATAMARAN SE SIJ Fusion System: 2025-12-23Sterilization Tray Assembly, Catamaran SE
• 00850033676570 - CATAMARAN SE SIJ Fusion System: 2025-12-23 Sterilization Tray Assembly, Catamaran SE
• 00850033676587 - Catamaran® SE SIJ Fusion System: 2025-12-23 Sterilization Tray Assembly, Catamaran Extraction Set
• 00850033676594 - Catamaran® SE SIJ Fusion System: 2025-12-23 Catamaran SE Instrument Set
• 00850033676600 - Catamaran® SE SIJ Fusion System: 2025-12-23 Catamaran Extraction Instrument Set
• 00850033676631 - Catamaran SI Joint Fusion System: 2025-12-23 Inserter
• 00850033676648 - Catamaran SI Joint Fusion System: 2025-12-23 Dual Port Loader
• 00850033676655 - Catamaran SE SI Joint Fusion System: 2025-12-23 LP Access Sleeve 7.5mm
• 00850033676662 - Catamaran SE SI Joint Fusion System: 2025-12-23 LP Drill Guide 7.5mm