ZIP 001-010-ZIP

GUDID B521001010ZIP0

ZIP ULTRA MIS Interspinous Fusion System, 10mm x 45mm

AURORA SPINE, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device IDB521001010ZIP0
NIH Device Record Key9a619a93-c3ef-46ef-98ea-8d2d635a42e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZIP
Version Model NumberULTRA
Catalog Number001-010-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
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us

Device Dimensions

Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter
Length45 Millimeter
Lumen/Inner Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB521001010ZIP0 [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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B5211040120350ZIP 51 MIS Interspinous Fusion System, 12mm x 35mm
B5211040100430ZIP 51 MIS Interspinous Fusion System, 10mm x 43mm
B5211040100410ZIP 51 MIS Interspinous Fusion System, 10mm x 41mm
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B5211030140400ZIP LP MIS Interspinous Fusion System, 14mm X 40mm
B5211030140350ZIP LP MIS Interspinous Fusion System, 14mm X 35mm
B5211030120450ZIP LP MIS Interspinous Fusion System, 12mm X 45mm
B5211030120400ZIP LP MIS Interspinous Fusion System, 12mm X 40mm
B5211030120350ZIP LP MIS Interspinous Fusion System, 12mm X 35mm
B5211030100450ZIP LP MIS Interspinous Fusion System, 10mm X 45mm
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B521001014ZIP0ZIP ULTRA MIS Interspinous Fusion System, 14mm x 45mm
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B521001014MZIP0ZIP ULTRA MIS Interspinous Fusion System, 14mm x 40mm
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B521001012MZIP0ZIP ULTRA MIS Interspinous Fusion System, 12mm x 40mm
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B521001010SZIP0ZIP ULTRA MIS Interspinous Fusion System, 10mm x 35mm
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B521001008ZIP0ZIP ULTRA MIS Interspinous Fusion System, 8mm x 45mm
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