CoFix Implant 12 mm RQI00012

GUDID 04260148898259

Paradigm Spine, LLC

Interspinous spinal fixation implant
Primary Device ID04260148898259
NIH Device Record Key7e373cf6-5991-4156-ad0c-4742b01cb592
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoFix Implant 12 mm
Version Model NumberRQI00012
Catalog NumberRQI00012
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

Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148898259 [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
04260148898242 - CoFix Implant 10 mm2020-03-27
04260148898259 - CoFix Implant 12 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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