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) (8) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (2)

Premarket Exempt

Yes No

Clear

ZIP - B5211040100390 Catalog Number : 104-010-039

Device Description : ZIP 51 MIS Interspinous Fusion System, 10mm x 39mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040100410 Catalog Number : 104-010-041

Device Description : ZIP 51 MIS Interspinous Fusion System, 10mm x 41mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040100430 Catalog Number : 104-010-043

Device Description : ZIP 51 MIS Interspinous Fusion System, 10mm x 43mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040120350 Catalog Number : 104-012-035

Device Description : ZIP 51 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 - B5211040120370 Catalog Number : 104-012-037

Device Description : ZIP 51 MIS Interspinous Fusion System, 12mm x 37mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040120390 Catalog Number : 104-012-039

Device Description : ZIP 51 MIS Interspinous Fusion System, 12mm x 39mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040120410 Catalog Number : 104-012-041

Device Description : ZIP 51 MIS Interspinous Fusion System, 12mm x 41mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211040120430 Catalog Number : 104-012-043

Device Description : ZIP 51 MIS Interspinous Fusion System, 12mm x 43mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

TiNano - B5211050000050 Catalog Number : 105-000-005

Device Description : DISCOVERY Cervical Interbody Fusion System, 12mm x 14mm x 0 degrees x 5mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

TiNano - B5211050000060 Catalog Number : 105-000-006

Device Description : DISCOVERY Cervical Interbody Fusion System, 12mm x 14mm x 0 degrees x 6mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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