Proficient® Posterior Cervical Spine System 10-8122

GUDID 10840642130256

Threaded Screwdriver, 3.0mm, NAV-M

Spine Wave, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10840642130256
• NIH Device Record Key: 218079a0-2423-4509-8443-1acc37de74bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proficient® Posterior Cervical Spine System
• Version Model Number: 10-8122
• Catalog Number: 10-8122
• Company DUNS: 067789763
• Company Name: Spine Wave, 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: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642130256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181596

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

[10840642130256]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-01-04

On-Brand Devices [Proficient® Posterior Cervical Spine System]

• 10840642142532: Proficient® Tap, Dual Lead 4.0mm, NAV-M
• 10840642142600: Proficient® Drill, 2.9 mm, Square, NAV-M
• 10840642142594: Proficient® Drill, 2.9 mm, AO, NAV-M
• 10840642142587: Proficient® Tap, Single Lead 4.1mm, NAV-M
• 10840642142570: Proficient® Tap, Single Lead 3.7mm, NAV-M
• 10840642142563: Proficient® Tap, Single Lead 3.1mm, NAV-M
• 10840642142556: Proficient® Tap, Dual Lead 5.0mm, NAV-M
• 10840642142549: Proficient® Tap, Dual Lead 4.5mm, NAV-M
• 10840642160765: Locking Screw, T15
• 10840642130270: XT Threaded Screwdriver, 3.0mm, NAV-M
• 10840642130263: XT Threaded Screwdriver, 2.5mm, NAV-M
• 10840642130256: Threaded Screwdriver, 3.0mm, NAV-M
• 10840642130249: Threaded Screwdriver, 2.5mm, NAV-M
• 10840642130232: Drill, Fixed, 2.9mm x 16mm, NAV-M
• 10840642130225: Drill, Fixed, 2.9mm x 14mm, NAV-M
• 10840642130218: Drill, Fixed, 2.9mm x 12mm, NAV-M
• 10840642130201: Drill, Fixed, 2.9mm x 10mm, NAV-M
• 10840642130195: Split Tip Screwdriver, 3.0mm, NAV-M
• 10840642130188: Split Tip Screwdriver, 2.5mm, NAV-M
• 10840642130171: Proficient® Tap, 5.5mm, NAV-M
• 10840642130164: Proficient® Tap, 5.0mm, NAV-M
• 10840642130157: Proficient® Tap, 4.5mm, NAV-M
• 10840642130140: Proficient® Tap, 4.0mm, NAV-M
• 10840642130133: Proficient® Tap, 4.1mm, NAV-M
• 10840642130126: Proficient® Tap, 3.7mm, NAV-M
• 10840642130119: Proficient® Tap, 3.3mm, NAV-M
• 10840642130102: Drill, 2.9mm, NAV-M
• 10840642130096: Probe, Straight, NAV-M
• 10840642130089: Awl, 2mm x 6mm, NAV-M