Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) 40308-01

GUDID B74240308010

Access Sleeve

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

• Primary Device ID: B74240308010
• NIH Device Record Key: f10bb312-0c72-4c33-8dc8-023872af9b13
• Commercial Distribution Discontinuation: 2021-12-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
• Version Model Number: 40308-01
• Catalog Number: 40308-01
• 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
HIBCC	B74240308010 [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

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

[B74240308010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-23
• Device Publish Date: 2020-06-12

On-Brand Devices [Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)]

• B74240308160: 7.5mm Insertion Handle
• B74240308150: 7.5mm Drill Spacer 5mm
• B74240308140: 7.5mm Drill Spacer 10mm
• B74240308130: 7.5mm Drill Spacer 20mm
• B74240308120: 7.5mm Drill Stop
• B74240308110: 7.5mm Extraction Screw
• B74240308100: 7.5mm Extraction Fork
• B74240308090: 7.5mm Bone Tamp Rod
• B74240308070: 7.5mm Location Pin
• B74240308060: 7.5mm Drill Guide
• B74240308050: 7.5mm Center Punch
• B74240308040: K-Wire
• B74240308030: Graduated Guide Wire
• B74240308020: Access Sleeve Handle
• B74240308010: Access Sleeve
• B74240295040: 10X40mm SIJ Implant
• B74240295030: 10X30mm SIJ Implant
• B74240295020: 7.5X40mm SIJ Implant
• B74240295010: 7.5X30mm SIJ Implant
• B742403250: Implant Sterilizing Tray (Trimmed)
• B742403240: Access Sterilizing Tray (Trimmed)
• B742403230: Extraction Sterilizing Tray (Trimmed)
• B742403220: Drill Sterilizing Tray (Trimmed)
• B74240308440: Drill Probe
• B74240308410: 7.5mm Drill
• B74240308400: 4mm Hex Key
• B74240308390: 10mm Bone Tamp Head
• B74240308380: 7.5mm Bone Tamp Head
• B74240308370: 10mm Funnel Flange
• B74240308360: 7.5mm Funnel Flange
• B74240308350: 10mm Funnel
• B74240308340: 7.5mm Funnel
• B74240308330: Handle Flange
• B74240308320: Slap Hammer Rod
• B74240308310: Slap Hammer Handle
• B74240308300: 10mm Insertion Screw
• B74240308290: 10mm Insertion Handle
• B74240308280: 10mm Drill Spacer 5mm
• B74240308270: 10mm Drill Spacer 10mm
• B74240308260: 10mm Drill Spacer 20mm
• B74240308250: 10mm Drill Stop
• B74240308240: 10mm Extraction Screw
• B74240308230: 10mm Extraction Fork
• B74240308220: 10mm Bone Tamp Rod
• B74240308210: 10mm Drill
• B74240308200: 10mm Location Pin
• B74240308190: 10mm Drill Guide
• B74240308180: 10mm Center Punch
• B74240308170: 7.5mm Insertion Screw