coflex Interlaminar Technology, 8mm

GUDID 04260148898457

Paradigm Spine, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable
Primary Device ID04260148898457
NIH Device Record Key33896ca6-913b-4cf9-ac40-29baf192ce76
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex Interlaminar Technology, 8mm
Version Model NumberUPI00008
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 Identifiers

Device Issuing AgencyDevice ID
GS104260148898457 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-07-28

On-Brand Devices [coflex Interlaminar Technology, 8mm]

04260148898501UQI00008
04260148898457UPI00008

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