CoFix Implant 8 mm RQI00008

GUDID 04260148898235

Paradigm Spine, LLC

Interspinous spinal fixation implant
Primary Device ID04260148898235
NIH Device Record Key4e272bc2-eab7-4c73-9c43-6cf19723b525
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoFix Implant 8 mm
Version Model NumberRQI00008
Catalog NumberRQI00008
Company DUNS787874960
Company NameParadigm Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148898235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous Process Plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-27
Device Publish Date2020-03-19

Devices Manufactured by Paradigm Spine, LLC

04260148898235 - CoFix Implant 8 mm2020-03-27
04260148898235 - CoFix Implant 8 mm2020-03-27
04260148898242 - CoFix Implant 10 mm2020-03-27
04260148898259 - CoFix Implant 12 mm2020-03-27
04260148898266 - CoFix Implant 14 mm2020-03-27
04260148898273 - CoFix Implant 16 mm2020-03-27
04260148897931 - CoFix Sterilization Tray2020-03-12
04260636670459 - coflex-F LIS screw inserter2020-03-12
04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm 2019-09-26

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