Siconus™ SI Joint Fixation System

GUDID B030SCL110650

Ø11mm Bone Screw, Cannulated, 65mm

CAMBER SPINE TECHNOLOGIES, LLC

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

• Primary Device ID: B030SCL110650
• NIH Device Record Key: 0d9a6e54-9795-4502-b461-07cb96df53a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Siconus™ SI Joint Fixation System
• Version Model Number: SCL-11-065
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Dimensions

• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter
• Outer Diameter: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030SCL110650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162121

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[B030SCL110650]

Moist Heat or Steam Sterilization

[B030SCL110650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2017-02-07

On-Brand Devices [Siconus™ SI Joint Fixation System]

• B030SCL110650: Ø11mm Bone Screw, Cannulated, 65mm
• B030SCL110600: Ø11mm Bone Screw, Cannulated, 60mm
• B030SCL110550: Ø11mm Bone Screw, Cannulated, 55mm
• B030SCL110500: Ø11mm Bone Screw, Cannulated, 50mm
• B030SCL110450: Ø11mm Bone Screw, Cannulated, 45mm
• B030SCL110400: Ø11mm Bone Screw, Cannulated, 40mm
• B030SCL110350: Ø11mm Bone Screw, Cannulated, 35mm
• B030SCL070700: Ø7mm Bone Screw, Cannulated, 70mm
• B030SCL070650: Ø7mm Bone Screw, Cannulated, 65mm
• B030SCL070600: Ø7mm Bone Screw, Cannulated, 60mm
• B030SCL070550: Ø7mm Bone Screw, Cannulated, 55mm
• B030SCL070500: Ø7mm Bone Screw, Cannulated, 50mm
• B030SCL070450: Ø7mm Bone Screw, Cannulated, 45mm
• B030SCL070400: Ø7mm Bone Screw, Cannulated, 40mm
• B030SCL070350: Ø7mm Bone Screw, Cannulated, 35mm
• B030SCL070300: Ø7mm Bone Screw, Cannulated, 30mm