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) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

TiNano - B5211120281208140 Catalog Number : 112-02812-0814

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm 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 - B521112028120814UC0 Catalog Number : 112-02812-0814-UC

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 14mm, UNCOATED

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

TiNano - B5211120281208150 Catalog Number : 112-02812-0815

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm 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 - B521112028120815UC0 Catalog Number : 112-02812-0815-UC

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 15mm, UNCOATED

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

TiNano - B5211120281208160 Catalog Number : 112-02812-0816

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 16mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Aurora Spine - B521112028120816UC0 Catalog Number : 112-02812-0816-UC

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 16mm, UNCOATED

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

TiNano - B5211120281208170 Catalog Number : 112-02812-0817

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 17mm

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Aurora Spine - B521112028120817UC0 Catalog Number : 112-02812-0817-UC

Device Description : ECHO SD Lumbar Interbody Fusion System, 28mm x 12mm x 8 degrees x 17mm, UNCOATED

Device Class : 2

Duns Number: 079119091

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

SILO - B5211133000 Catalog Number :

Device Description : SILO, DILATOR

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SILO - B5211133010 Catalog Number :

Device Description : SILO, MIS TUBE

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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