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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (9)

Premarket Exempt

No Yes

Clear

AURORA SPINE - B521C190120080 Catalog Number : C19-012-008

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 8mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120090 Catalog Number : C19-012-009

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 9mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120100 Catalog Number : C19-012-010

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 10mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120110 Catalog Number : C19-012-011

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 11mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120120 Catalog Number : C19-012-012

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 12mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120130 Catalog Number : C19-012-013

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 13mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120140 Catalog Number : C19-012-014

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 14mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120150 Catalog Number : C19-012-015

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 15mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190120160 Catalog Number : C19-012-016

Device Description : VOX, TRIAL-L, HUDSON, BENT, 60mm x 18mm x 8 degrees x 16mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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