coflex single-use instruments

GUDID 04260148898358

Paradigm Spine, LLC

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID04260148898358
NIH Device Record Keyfc64902d-e164-4d79-a2ad-4f61c3af89a1
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex single-use instruments
Version Model NumberUST00300
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148898358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-16
Device Publish Date2018-06-14

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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