Whistler Modular Pedicle Screw System WRC5545-T

GUDID 00195860000311

Ti Curved Rod, 5.5 Dia x 45 mm

Evolution Spine LLC

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00195860000311
• NIH Device Record Key: 0521a7cb-b6f6-437a-86da-56a01b47a216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Whistler Modular Pedicle Screw System
• Version Model Number: WRC5545-T
• Catalog Number: WRC5545-T
• Company DUNS: 116940934
• Company Name: Evolution Spine 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: 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

Customer Support Contacts

• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182478

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

[00195860000311]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [Whistler Modular Pedicle Screw System]

• 00195860000045: Locking Cap, Solid, 6.0mm
• 00195860000038: Locking Cap, Cannulated, 6.0 mm
• 00195860000021: Locking Cap, Solid
• 00195860000014: Locking Cap, Cannulated
• 00195860004579: DIA 10.5 x 75mm, Solid, HA
• 00195860004432: DIA 10.5 x 75mm, Solid
• 00195860004296: DIA 9.5 x 75mm, Solid, HA
• 00195860004159: DIA 9.5 x 75mm, Solid
• 00195860012239: MIS Locking Cap Starter
• 00195860012222: Tulip Inserter Forceps
• 00195860012567: MIS Rod Caddy + Lid
• 00195860012550: Open Rod Caddy + Lid
• 00195860012543: Screw Caddy Lid
• 00195860012536: 10.5mm Screw Caddy
• 00195860012529: 9.5mm Screw Caddy
• 00195860012512: 8.5mm Screw Caddy
• 00195860012505: 8.0mm Screw Caddy
• 00195860012499: 7.5mm Screw Caddy
• 00195860012482: 7.0mm Screw Caddy
• 00195860012475: 6.5mm Screw Caddy
• 00195860012468: 6.0mm Screw Caddy
• 00195860012451: 5.5mm Screw Caddy
• 00195860012444: 4.75mm Screw Caddy
• 00195860012437: Tulip Caddy + Lid
• 00195860012420: Solid Locking Cap Caddy + Lid
• 00195860012413: Cannulated Locking Cap Caddy + Lid
• 00195860012406: Rod Caddy + Lid
• 00195860012390: Implant Case Lid
• 00195860012383: Implant Case
• 00195860012376: MODULAR REDUCTION TULIP INSERTER, THD, 8 INCH
• 00195860012369: ROD ROCKER ASSEMBLY, LONG
• 00195860012352: Screw Gauge
• 00195860012345: FINAL TIGHTENING DRIVER, 8.5 INCH
• 00195860012338: MIS ROD INSERTER
• 00195860005453: Whistler Instrument Case 3 Tray 2
• 00195860005446: Whistler Instrument Case 3 Tray 1
• 00195860005439: Whistler Instrument Case 3 Lid
• 00195860005422: Whistler Instrument Case 2 Tray 2
• 00195860005415: Whistler Instrument Case 2 Tray 1
• 00195860005408: Whistler Instrument Case 2 Lid
• 00195860005392: Whistler Instrument Case 1 Tray 2
• 00195860005385: Whistler Instrument Case 1 Tray 1
• 00195860005378: Whistler Instrument Case 1 Lid
• 00195860005361: Rod Gripper
• 00195860005354: Ratcheting T-Handle
• 00195860005347: Compressor
• 00195860005330: Distractor
• 00195860005323: 5.5mm Double Action Gripper
• 00195860005316: Straight Ratcheting Handle
• 00195860005309: Flexible Rod Template