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 - B521001008MZIP0 Catalog Number : 001-008-M-ZIP

Device Description : ZIP ULTRA MIS Interspinous Fusion System, 8mm x 40mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B521001008SZIP0 Catalog Number : 001-008-S-ZIP

Device Description : ZIP ULTRA 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 - B521001008ZIP0 Catalog Number : 001-008-ZIP

Device Description : ZIP ULTRA 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 - B521001010MZIP0 Catalog Number : 001-010-M-ZIP

Device Description : ZIP ULTRA 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 - B521001010SZIP0 Catalog Number : 001-010-S-ZIP

Device Description : ZIP ULTRA 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 - B521001010ZIP0 Catalog Number : 001-010-ZIP

Device Description : ZIP ULTRA 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 - B521001012MZIP0 Catalog Number : 001-012-M-ZIP

Device Description : ZIP ULTRA 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 - B521001012SZIP0 Catalog Number : 001-012-S-ZIP

Device Description : ZIP ULTRA 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 - B521001012ZIP0 Catalog Number : 001-012-ZIP

Device Description : ZIP ULTRA 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 - B521001014MZIP0 Catalog Number : 001-014-M-ZIP

Device Description : ZIP ULTRA 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

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