CervAlign™ Anterior Cervical Plate System 66-FST-45-14

GUDID 00846468087937

Fixed Self Tapping Rescue Screw

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 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 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 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: 00846468087937
• NIH Device Record Key: 46c1b7a5-ac69-40b4-8c2a-b86d1dfffd20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CervAlign™ Anterior Cervical Plate System
• Version Model Number: 66-FST-45-14
• Catalog Number: 66-FST-45-14
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• 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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468087937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183060
• Premarket Notification: K211408

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

[00846468087937]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-20

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

• 00846468088255: Temporary Plate Holding Threaded Pin
• 00846468088248: Temporary Plate Holding Push Pin
• 00846468088231: Modular Tap
• 00846468088224: Modular Tap
• 00846468088217: Modular Tap
• 00846468088200: Modular Tap
• 00846468088194: Modular Tap
• 00846468088187: Modular Tap
• 00846468088170: Modular Drill
• 00846468088163: Modular Drill
• 00846468088156: Modular Drill
• 00846468088149: Modular Drill
• 00846468088132: Modular Drill
• 00846468088125: Modular Drill
• 00846468088118: Variable Guide
• 00846468088101: Fixed Guide
• 00846468088095: Driver, Tapered
• 00846468088088: Driver, Stab And Grab
• 00846468088071: Plate Holder
• 00846468088064: Plate Bender
• 00846468088057: Modular Handle
• 00846468088040: DTS Guide
• 00846468088033: DTS Guide
• 00846468088026: DTS Guide
• 00846468088019: DTS Guide
• 00846468088002: DTS Fork
• 00846468087999: Plate Sizing Caliper
• 00846468087982: Bone Awl
• 00846468087975: Awl Sleeve
• 00846468087968: Fixed Self Tapping Rescue Screw
• 00846468087951: Fixed Self Tapping Rescue Screw
• 00846468087944: Fixed Self Tapping Rescue Screw
• 00846468087937: Fixed Self Tapping Rescue Screw
• 00846468087920: Fixed Self Tapping Rescue Screw
• 00846468087913: Fixed Self Tapping Rescue Screw
• 00846468087906: Variable Self Tapping Rescue Screw
• 00846468087890: Variable Self Tapping Rescue Screw
• 00846468087883: Variable Self Tapping Rescue Screw
• 00846468087876: Variable Self Tapping Rescue Screw
• 00846468087869: Variable Self Tapping Rescue Screw
• 00846468087852: Variable Self Tapping Rescue Screw
• 00846468087845: Fixed Self Tapping Screw
• 00846468087838: Fixed Self Tapping Screw
• 00846468087821: Fixed Self Tapping Screw
• 00846468087814: Fixed Self Tapping Screw
• 00846468087807: Fixed Self Tapping Screw
• 00846468087791: Fixed Self Tapping Screw
• 00846468087784: Fixed Self Drilling Screw
• 00846468087777: Fixed Self Drilling Screw
• 00846468087760: Fixed Self Drilling Screw