primaLOK FF

GUDID 00813210022003

Removal Driver

WENZEL SPINE, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00813210022003
• NIH Device Record Key: 51b7c0a4-e5eb-49bc-a6e4-2874921aafea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primaLOK FF
• Version Model Number: 800-1203
• Company DUNS: 832543255
• Company Name: WENZEL SPINE, 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: 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: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com
• Phone: 855-936-9389
• Email: info@wenzelspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813210022003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102438

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

[00813210022003]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-06-26

On-Brand Devices [primaLOK FF]

• 00813210022034: Threaded Implant Holder Shaft - Solid
• 00813210022027: Threaded Implant Holder Shaft - Cannulated
• 00813210022010: Implant Driver
• 00813210022003: Removal Driver
• 00813210021990: primaLOK FF 45mm Implant Assembly, Sterile
• 00813210021983: primaLOK FF 40mm Implant Assembly, Sterile
• 00813210021976: primaLOK FF 35mm Implant Assembly, Sterile
• 00813210021969: primaLOK FF 30mm Implant Assembly, Sterile
• 00813210021952: primaLOK FF 25mm Implant Assembly, Sterile
• 00813210022157: 3mm Cannulated Power Drill
• 00813210022133: Ratcheting Driver Handle
• 00813210022126: Cannula Inserter
• 00813210022119: Single Bevel Access Needle (sterile, single use)
• 00813210022102: Access Needle (sterile, single use)
• 00813210022096: EMG Cannula
• 00813210022089: Standard Cannula
• 00813210022072: Guide Wire Stiffener
• 00813210022065: Cannulated Tap
• 00813210022041: Guide Wire (single use, disposable)
• 00813210021945: Percutaneous Instrument Case
• 00813210021938: Instrument Case