Catamaran® SIJ Fusion System 40362

GUDID 00850033676310

LP Access Sleeve 10mm, Catamaran

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850033676310
• NIH Device Record Key: fc5e5473-b03a-4e73-a2c7-cb2000ccbeb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catamaran® SIJ Fusion System
• Version Model Number: 40362
• Catalog Number: 40362
• 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	00850033676310 [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

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

[00850033676310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [Catamaran® SIJ Fusion System]

• 00850033676396: Catamaran JIB Set
• 00850033676389: Sterilization Tray Assembly, JIB Set
• 00850033676372: Graft Remover 10mm, Catamaran
• 00850033676365: Loader Funnel 10mm, Catamaran
• 00850033676358: K-Wire Driver, Catamaran
• 00850033676341: LP Inserter Screw 10mm, Catamaran
• 00850033676334: LP Inserter 10mm, Catamaran
• 00850033676327: LP Drill Guide 10mm, Catamaran
• 00850033676310: LP Access Sleeve 10mm, Catamaran