CODA™ Anterior Cervical Plate System 1022-03-042

GUDID 00840298701209

3 Level Plate

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840298701209
• NIH Device Record Key: b753a70b-a909-4195-8f32-4f8ecae52ddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODA™ Anterior Cervical Plate System
• Version Model Number: 58-102203042
• Catalog Number: 1022-03-042
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labelrequests@resolvesurg.com

Device Dimensions

• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840298701209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222493

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

[00840298701209]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-01-19

On-Brand Devices [CODA™ Anterior Cervical Plate System]

• 00840298703678: Screw Loading Block
• 00840298703661: 5 Level Template Caddy
• 00840298703654: 4 Level Template Caddy
• 00846468032913: 3 Level Template Caddy
• 00846468005382: 2 Level Template Caddy
• 00846468005375: 1 Level Template Caddy
• 00846468005368: Template Tray 4-5
• 00846468005351: Template Tray 1-3
• 00846468005344: 5 Level Plate Caddy
• 00846468005337: 4 Level Plate Caddy
• 00846468005313: 3 Level Plate Caddy
• 00846468005306: 2 Level Plate Caddy
• 00846468005290: 1 Level Plate Caddy
• 00846468005283: Constrained Screw Caddy
• 00846468005276: Variable Screw Caddy
• 00846468005269: Screw And Plate Tray 4-5
• 00846468005252: Screw And Plate Tray 1-3
• 00846468005238: Half Tray Lid
• 00846468005221: Intradiscal Guide Tray
• 00846468005214: Full Tray Lid
• 00846468005207: Standard Instrument Tray
• 00846468005191: Template Half Tray 4-5
• 00846468005184: Template Half Tray 1-3
• 00840298703609: Rescue Constrained Self Tapping Screw
• 00840298703593: Rescue Constrained Self Tapping Screw
• 00840298703586: Rescue Constrained Self Tapping Screw
• 00840298703579: Rescue Constrained Self Tapping Screw
• 00840298703517: Primary Constrained Self Tapping Screw
• 00840298703494: Primary Constrained Self Tapping Screw
• 00840298703470: Primary Constrained Self Tapping Screw
• 00840298703463: Primary Constrained Self Tapping Screw
• 00840298703456: Primary Constrained Self Tapping Screw
• 00840298703449: Primary Constrained Self Tapping Screw
• 00840298703432: Primary Constrained Self Tapping Screw
• 00840298703425: Primary Constrained Self Tapping Screw
• 00840298703418: Primary Constrained Self Tapping Screw
• 00840298703401: Primary Constrained Self Tapping Screw
• 00840298703395: Primary Constrained Self Tapping Screw
• 00840298703173: Rescue Variable Self Tapping Screw
• 00840298703166: Rescue Variable Self Tapping Screw
• 00840298703159: Rescue Variable Self Tapping Screw
• 00840298703142: Rescue Variable Self Tapping Screw
• 00840298703081: Primary Variable Self Tapping Screw
• 00840298703067: Primary Variable Self Tapping Screw
• 00840298703043: Primary Variable Self Tapping Screw
• 00840298703036: Primary Variable Self Tapping Screw
• 00840298703029: Primary Variable Self Tapping Screw
• 00840298703012: Primary Variable Self Tapping Screw
• 00840298703005: Primary Variable Self Tapping Screw
• 00840298702992: Primary Variable Self Tapping Screw