Canaveral® 01-1275-30

GUDID B183112750300

Reduction Polyaxial Screw Assembly, 7.5mm x 30mm

FLOSPINE LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B183112750300
• NIH Device Record Key: c09f5556-fb5d-4352-80f7-b9adae63e0fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canaveral®
• Version Model Number: Canaveral®
• Catalog Number: 01-1275-30
• Company DUNS: 042993143
• Company Name: FLOSPINE 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: (561) 705-3080
• Email: info@flospine.com
• Phone: (561) 705-3080
• Email: info@flospine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B183112750300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141850

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[B183112750300]

Moist Heat or Steam Sterilization

[B183112750300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-30

On-Brand Devices [Canaveral®]

• B183180050010: Generic Instrument Tray
• B183180040020: Tray, Deformity Implant Case 1
• B183180040010: Base, Deformity Implant Case 1
• B183180000100: 5.5mm Rod Caddy
• B183180000090: 8.5mm Screw Caddy, Core Screw Set
• B183180000080: 7.5mm Screw Caddy, Core Screw Set
• B183180000070: 6.5mm Screw Caddy, Core Screw Set
• B183180000060: 5.5mm Screw Caddy, Core Screw Set
• B183180000050: 4.5mm Screw Caddy, Core Screw Set
• B183180000040: Set Screw Caddy, Core Screw Set
• B183180000030: Tray, Core Screw Set
• B183180000020: Lid, Canaveral Pedicle Screw System
• B183180000010: Base, Core Screw Set
• B183173000090: Nav Modular Screwdriver
• B183173000080: Nav Polyaxial Screwdriver
• B183173000070: Nav Screw Tap, 10.5mm
• B183173000060: Nav Screw Tap, 9.5mm
• B183173000050: Nav Screw Tap, 8.5mm
• B183173000040: Nav Screw Tap, 7.5mm
• B183173000030: Nav Screw Tap, 6.5mm
• B183173000020: Nav Screw Tap, 5.5mm
• B183173000010: Nav Screw Tap, 4.5mm
• B183171000370: Palm Ratcheting Handle
• B183171000360: 1/4" Adapter, Reducer
• B183171000350: Palm Handle, Hood Driver
• B183171000340: Hood Driver - Final Tightening
• B183171000330: Ratcheting Box Wrench
• B183171000320: In-Situ Bender 5.5mm, Right
• B183171000310: In-Situ Bender 5.5mm, Left
• B183171000300: Coronal Bender 5.5mm, Right
• B183171000290: Coronal Bender 5.5mm, Left
• B183171000280: Headbody Manipulator
• B183171000270: Closed Polyaxial Screwdriver, Short
• B183171000260: Reduction Crown
• B183171000250: In-Situ Rod Bender, Right
• B183171000240: In-Situ Rod Bender, Left
• B183171000230: Right Coronal Bender
• B183171000220: Left Coronal Bender
• B183171000140: T-Handle
• B183171000130: T-Handle Torque Wrench - 90inlb
• B183171000120: 2.4mm Drill (nonserile disposable)
• B183171000110: Driver - Final Tightening
• B183171000100: Power vice grips
• B183171000090: Derotation Tube
• B183171000080: Reduction, Derotation Tower
• B183171000070: Palm Style Non-Ratcheting Handle
• B183171000060: Monoaxial Screwdriver, Reduction
• B183171000050: Monoaxial Screwdriver,
• B183171000040: Polyaxial Screwdriver, Short Reduction
• B183171000030: Polyaxial Screwdriver, Short