Sterile Spine Pedicle Screw System 06.6581B-WB

GUDID B562066581BWB0

Ø5.5 Polyaxial Pedicle Screw, Cannulated , w/Cap Ø6.5 X 40mm (Green)

WISHBONE MEDICAL, INC.

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• Primary Device ID: B562066581BWB0
• NIH Device Record Key: abc6038f-8544-409b-87ea-bfb887f9361f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Spine Pedicle Screw System
• Version Model Number: 06.6581B-WB
• Catalog Number: 06.6581B-WB
• Company DUNS: 062355158
• Company Name: WISHBONE 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	B562066581BWB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121786

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-27
• Device Publish Date: 2022-07-19

On-Brand Devices [Sterile Spine Pedicle Screw System]

• B56246072504WB0: Ø5.5 Set Screw 1 (Locking Cap)
• B56244120202WB0: Ø5.5 Set Screw 3 (Locking Cap)
• B562066641BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø5.5 X 60mm (Blue)
• B562066641B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø5.5 X 60mm (Blue)
• B562066640BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø5.5 X 55mm (Blue)
• B562066640B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø5.5 X 55mm (Blue)
• B562066639BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 80mm (Green)
• B562066639B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 80mm (Green)
• B562066638BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 70mm (Green)
• B562066638B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 70mm (Green)
• B562066637BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 60mm (Green)
• B562066637B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 60mm (Green)
• B562066636BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 55mm (Green)
• B562066636B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 55mm (Green)
• B562066635BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 50mm (Green)
• B562066635B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 50mm (Green)
• B562066634BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 45mm (Green)
• B562066634B1WB2: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 45mm (Green)
• B562066633BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø6.5 X 40mm (Green)
• B562066633B1WB1: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø6.5 X 40mm (Green)
• B562066632BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø5.5 X 50mm (Blue)
• B562066632B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø5.5 X 50mm (Blue)
• B562066631BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø5.5 X 45mm (Blue)
• B562066631B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø5.5 X 45mm (Blue)
• B562066630BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab Ø5.5 X 40mm (Blue)
• B562066630B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, Extended Tab, w/Cap Ø5.5 X 40mm (Blue)
• B562066617BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 90mm (Yellow)
• B562066617B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 90mm (Yellow)
• B562066616BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 80mm (Yellow)
• B562066616B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 80mm (Yellow)
• B562066615BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 70mm (Yellow)
• B562066615B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 70mm (Yellow)
• B562066614BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 60mm (Yellow)
• B562066614B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 60mm (Yellow)
• B562066613BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 55mm (Yellow)
• B562066613B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 55mm (Yellow)
• B562066612BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 50mm (Yellow)
• B562066612B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 50mm (Yellow)
• B562066611BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 45mm (Yellow)
• B562066611B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 45mm (Yellow)
• B562066610BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø8.0 X 40mm (Yellow)
• B562066610B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø8.0 X 40mm (Yellow)
• B562066608BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø7.5 X 90mm (Violet)
• B562066608B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø7.5 X 90mm (Violet)
• B562066607BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø7.5 X 80mm (Violet)
• B562066607B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø7.5 X 80mm (Violet)
• B562066606BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø7.5 X 70mm (Violet)
• B562066606B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø7.5 X 70mm (Violet)
• B562066605BWB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated Ø7.5 X 60mm (Violet)
• B562066605B1WB0: Ø5.5 Polyaxial Pedicle Screw, Cannulated, w/Cap Ø7.5 X 60mm (Violet)