Catamaran® SE SIJ Fusion System 40410

GUDID 00850033676563

LP Extraction Fork 7.5mm, Catamaran

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850033676563
• NIH Device Record Key: 10d7dda0-c3be-4f34-905c-ef0d3660fad7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catamaran® SE SIJ Fusion System
• Version Model Number: 40410
• Catalog Number: 40410
• Company DUNS: 117014636
• Company Name: TENON MEDICAL, 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: false
• 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	00850033676563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180818

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

[00850033676563]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [Catamaran® SE SIJ Fusion System]

• 00850033676563: LP Extraction Fork 7.5mm, Catamaran
• 00850033676549: Graft Funnel, Double, 7.5mm, Catamaran
• 00850033676532: Graft Remover, 7.5mm, Catamaran
• 00850033676457: LP Drill Guide, 7.5mm, Catamaran
• 00850033676440: LP Access Sleeve, 7.5mm, Catamaran
• 00850033676433: LP Inserter Screw, 7.5mm, Catamaran
• 00850033676426: LP Inserter, 7.5mm, Catamaran
• 00850033676419: Implant, CAT-01, 7.5mm X 40mm, Catamaran
• 00850033676402: Implant, CAT-01, 7.5mm X 30mm, Catamaran