coflex trial with guide and x-ray marker, 16mm

GUDID 04260148897788

Paradigm Spine, LLC

Orthopaedic prosthesis implantation instrument, reusable

Primary Device ID	04260148897788
NIH Device Record Key	8222c450-fb1a-4efc-a7b2-e70b2c320969
Commercial Distribution Status	In Commercial Distribution
Brand Name	coflex trial with guide and x-ray marker, 16mm
Version Model Number	UXT10016
Company DUNS	787874960
Company Name	Paradigm Spine, LLC
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260148897788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P110008

FDA Product Code

NQO	Prosthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

[04260148897788]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-07-30
Device Publish Date	2018-06-28

Devices Manufactured by Paradigm Spine, LLC

04260148898235 - CoFix Implant 8 mm	2020-03-27
04260148898242 - CoFix Implant 10 mm	2020-03-27
04260148898259 - CoFix Implant 12 mm	2020-03-27
04260148898266 - CoFix Implant 14 mm	2020-03-27
04260148898273 - CoFix Implant 16 mm	2020-03-27
04260148897931 - CoFix Sterilization Tray	2020-03-12
04260636670459 - coflex-F LIS screw inserter	2020-03-12
04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm	2019-09-26

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