Proficient® Posterior Cervical Spine System

GUDID 10840642160765

Locking Screw, T15

Spine Wave, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10840642160765
• NIH Device Record Key: 59257140-50fc-47bc-b68f-bcb90af24004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proficient® Posterior Cervical Spine System
• Version Model Number: 11-8555
• 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: 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: 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
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642160765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181440

FDA Product Code

• NKG: Orthosis, Cervical Pedicle Screw Spinal Fixation

Sterilization

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

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

[10840642160765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-19
• Device Publish Date: 2021-05-11

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