Whistler Pedicle Screw System WI-079

GUDID 00195860030028

Rod Caliper

Evolution Spine LLC

General-purpose calliper, metallic

• Primary Device ID: 00195860030028
• NIH Device Record Key: b075e922-e985-409a-a991-5e50c62c747f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Whistler Pedicle Screw System
• Version Model Number: WI-079
• Catalog Number: WI-079
• 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: false
• 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)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860030028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182478

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-29

Devices Manufactured by Evolution Spine LLC

• 00195860031803 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 14mm 7DEG 5mm-6mm
• 00195860031810 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 14mm 7DEG 7mm-8mm
• 00195860031827 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 14mm 7DEG 9mm-10mm
• 00195860031834 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 14mm 7DEG 11mm-12mm
• 00195860031841 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 16mm 7DEG 5mm-6mm
• 00195860031858 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 16mm 7DEG 7mm-8mm
• 00195860031865 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 16mm 7DEG 9mm-10mm
• 00195860031872 - E3D-C Interbody System: 2026-03-02 TRIAL 20 X 16mm 7DEG 11mm-12mm