ZIP 001-018-ZIP

GUDID B521001018ZIP0

ZIP ULTRA MIS Interspinous Fusion System, 18mm x 45mm

AURORA SPINE, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device IDB521001018ZIP0
NIH Device Record Key7f230dc8-44be-489c-881f-b1ff5cf580e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameZIP
Version Model NumberULTRA
Catalog Number001-018-ZIP
Company DUNS079119091
Company NameAURORA SPINE, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us

Device Dimensions

Length45 Millimeter
Lumen/Inner Diameter18 Millimeter
Length45 Millimeter
Lumen/Inner Diameter18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB521001018ZIP0 [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 Date2019-03-11
Device Publish Date2019-03-01

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