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) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Aurora Spine - B5210010280 Catalog Number : 001-028

Device Description : ZIP GRAFTING STATION

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210010290 Catalog Number : 001-029

Device Description : ZIP COMPRESSOR, SMALL

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210010300 Catalog Number : 001-030

Device Description : ZIP, INSTRUMENT CASE

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210010310 Catalog Number : 001-031

Device Description : ZIP INSTRUMENT SET

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210010320 Catalog Number : 001-032

Device Description : ZIP IMPLANT HOLDER

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210010370 Catalog Number : 001-037

Device Description : ZIP IMPLANT LOCATOR

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B52100104045 Catalog Number :

Device Description : ZIP All-In-One Compressor 45mm

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Aurora Spine - B5210013030 Catalog Number : 001-303

Device Description : ZIP ULTRA, SHORT COMPRESSOR

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : PEK

Prescription Use : Yes

Device Count : 1

ZIP - B5211030080350 Catalog Number : 103-008-035

Device Description : ZIP LP 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 - B5211030080400 Catalog Number : 103-008-040

Device Description : ZIP LP 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

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