CervAlign™ Anterior Cervical Plate System 66-FST-40-14
GUDID 00846468087814
Fixed Self Tapping Screw
Pioneer Surgical Technology, Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00846468087814 |
| NIH Device Record Key | 93c2b80e-4bac-4220-9ca2-87945b177a8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CervAlign™ Anterior Cervical Plate System |
| Version Model Number | 66-FST-40-14 |
| Catalog Number | 66-FST-40-14 |
| 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 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Dimensions
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468087814 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
Moist Heat or Steam Sterilization
[00846468087814]
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 |
Trademark Results [CervAlign]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERVALIGN 88037029 not registered Live/Pending |
Pioneer Surgical Technology, Inc. 2018-07-13 |
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