Calvary Spine Pedicle Screw System 18540

GUDID B11485400

Polyaxial Screw 8.5mm Diameter 40mm length

CALVARY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B11485400
• NIH Device Record Key: 9cf806c5-9e4a-469a-82a7-a85a1e6257bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calvary Spine Pedicle Screw System
• Version Model Number: 18540
• Catalog Number: 18540
• Company DUNS: 832116532
• Company Name: CALVARY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	B11485400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201568

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

[B11485400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [Calvary Spine Pedicle Screw System]

• B165350: Polyaxial Screw 7.5mm Diameter 35mm length
• B115185450: Polyaxial Screw 8.5mm Diameter 45mm length
• B11485400: Polyaxial Screw 8.5mm Diameter 40mm length
• B1148500: Illiac Connector 5.5mm Diameter 50mm Rod Length
• B1148300: Illiac Connector 5.5mm Diameter 30mm Rod Length
• B11475550: Polyaxial Screw 7.5mm Diameter 55mm length
• B11475500: Polyaxial Screw 7.5mm Diameter 50mm length
• B11475300: Polyaxial Screw 7.5mm Diameter 30mm length
• B1145900: PreLordosed Rod 5.5mm Diameter 90mm length Ti6Al4V
• B1145800: PreLordosed Rod 5.5mm Diameter 80mm length Ti6Al4V
• B1145700: PreLordosed Rod 5.5mm Diameter 70mm length Ti6Al4V
• B1145600: PreLordosed Rod 5.5mm Diameter 60mm length Ti6Al4V
• B1145500: PreLordosed Rod 5.5mm Diameter 50mm length Ti6Al4V
• B11454800: Straight Rod 5.5mm Diameter 480mm length Ti6Al4V
• B1145450: PreLordosed Rod 5.5mm Diameter 45mm length Ti6Al4V
• B1145400: PreLordosed Rod 5.5mm Diameter 40mm length Ti6Al4V
• B1145350: PreLordosed Rod 5.5mm Diameter 35mm length Ti6Al4V
• B1145300: PreLordosed Rod 5.5mm Diameter 30mm length Ti6Al4V
• B11452400: PreLordosed Rod 5.5mm Diameter 240mm length Ti6Al4V
• B11451000: PreLordosed Rod 5.5mm Diameter 100mm length Ti6Al4V
• B114185900: Polyaxial Screw 8.5mm Diameter 90mm length
• B114185800: Polyaxial Screw 8.5mm Diameter 80mm length
• B114185700: Polyaxial Screw 8.5mm Diameter 70mm length
• B114185600: Polyaxial Screw 8.5mm Diameter 60mm length
• B114185550: Polyaxial Screw 8.5mm Diameter 55mm length
• B114185500: Polyaxial Screw 8.5mm Diameter 50mm length
• B11418535: Polyaxial Screw 8.5mm Diameter 35mm length
• B114185300: Polyaxial Screw 8.5mm Diameter 30mm length
• B114175600: Polyaxial Screw 7.5mm Diameter 60mm length
• B114175450: Polyaxial Screw 7.5mm Diameter 45mm length
• B114175400: Polyaxial Screw 7.5mm Diameter 40mm length
• B114165600: Polyaxial Screw 6.5mm Diameter 60mm length
• B114165550: Polyaxial Screw 6.5mm Diameter 55mm length
• B114165500: Polyaxial Screw 6.5mm Diameter 50mm length
• B114165450: Polyaxial Screw 6.5mm Diameter, 45mm length
• B114165400: Polyaxial Screw 6.5mm Diameter 40mm length
• B114165350: Polyaxial Screw 6.5mm Diameter 35mm length
• B114165300: Polyaxial Screw 6.5mm Diameter 30mm length
• B114155600: Polyaxial Screw 5.5mm Diameter 60mm length
• B114155550: Polyaxial Screw 5.5mm Diameter 55mm length
• B114155500: Polyaxial Screw 5.5mm Diameter 50mm length
• B114155450: Polyaxial Screw 5.5mm Diameter 45mm length
• B114155400: Polyaxial Screw 5.5mm 40 mm Length
• B114155350: Polyaxial Screw 5.5mm Diameter 35mm length
• B114155300: Polyaxial Screw 5.5mm diameter 30mm length
• B114155250: Polyaxial Screw 5.5mm Diameter 25 mm length
• B11410010: Locking Cap