coflex Trial with lower wings

GUDID 04260148898860

Paradigm Spine, LLC

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID04260148898860
NIH Device Record Key67b8ca61-16f0-4e6d-948d-ec138ccee7e9
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex Trial with lower wings
Version Model NumberUDT10007
Company DUNS787874960
Company NameParadigm Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148898860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


[04260148898860]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-29

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
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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