AURORA SPINE, INC.

Address:1930 Palomar Point Way,Carlsbad,CA,92008,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Spinous Process Plate (PEK) (10)

Premarket Exempt

No Yes

Clear

ZIP - B5211030080450 Catalog Number : 103-008-045

Device Description : ZIP LP MIS Interspinous Fusion System, 8mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030100350 Catalog Number : 103-010-035

Device Description : ZIP LP MIS Interspinous Fusion System, 10mm X 35mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030100400 Catalog Number : 103-010-040

Device Description : ZIP LP MIS Interspinous Fusion System, 10mm X 40mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030100450 Catalog Number : 103-010-045

Device Description : ZIP LP MIS Interspinous Fusion System, 10mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030120350 Catalog Number : 103-012-035

Device Description : ZIP LP MIS Interspinous Fusion System, 12mm X 35mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030120400 Catalog Number : 103-012-040

Device Description : ZIP LP MIS Interspinous Fusion System, 12mm X 40mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030120450 Catalog Number : 103-012-045

Device Description : ZIP LP MIS Interspinous Fusion System, 12mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030140350 Catalog Number : 103-014-035

Device Description : ZIP LP MIS Interspinous Fusion System, 14mm X 35mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030140400 Catalog Number : 103-014-040

Device Description : ZIP LP MIS Interspinous Fusion System, 14mm X 40mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030140450 Catalog Number : 103-014-045

Device Description : ZIP LP MIS Interspinous Fusion System, 14mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

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