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

Yes No

Clear

ZIP - B5211030160400 Catalog Number : 103-016-040

Device Description : ZIP LP MIS Interspinous Fusion System, 16mm X 40mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030160450 Catalog Number : 103-016-045

Device Description : ZIP LP MIS Interspinous Fusion System, 16mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030180450 Catalog Number : 103-018-045

Device Description : ZIP LP MIS Interspinous Fusion System, 18mm X 45mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040080350 Catalog Number : 104-008-035

Device Description : ZIP 51 MIS Interspinous Fusion System, 8mm x 35mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040080370 Catalog Number : 104-008-037

Device Description : ZIP 51 MIS Interspinous Fusion System, 8mm x 37mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040080390 Catalog Number : 104-008-039

Device Description : ZIP 51 MIS Interspinous Fusion System, 8mm x 39mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040080410 Catalog Number : 104-008-041

Device Description : ZIP 51 MIS Interspinous Fusion System, 8mm x 41mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040080430 Catalog Number : 104-008-043

Device Description : ZIP 51 MIS Interspinous Fusion System, 8mm x 43mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040100350 Catalog Number : 104-010-035

Device Description : ZIP 51 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 - B5211040100370 Catalog Number : 104-010-037

Device Description : ZIP 51 MIS Interspinous Fusion System, 10mm x 37mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

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