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

Orthopedic Manual Surgical Instrument (LXH) (10)

Premarket Exempt

No Yes

Clear

AURORA SPINE - B521C1900730 Catalog Number : C19-007-3

Device Description : COBB, 17mm, TIP BEND, 10 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900740 Catalog Number : C19-007-4

Device Description : COBB, 17mm, BEND, 10 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900750 Catalog Number : C19-007-5

Device Description : COBB, 17mm, BEND, 20 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900760 Catalog Number : C19-007-6

Device Description : COBB, 17mm, BEND, 15 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900770 Catalog Number : C19-007-7

Device Description : COBB, 17mm, DOUBLE BEND

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900810 Catalog Number : C19-008-1

Device Description : CURETTE, 11mm, DOUBLE BEND

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900820 Catalog Number : C19-008-2

Device Description : CURETTE, 11mm, TIP BEND, 15 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900830 Catalog Number : C19-008-3

Device Description : CURETTE, 11mm, BEND, 15 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C1900840 Catalog Number : C19-008-4

Device Description : CURETTE, 11mm, BEND, 20 degrees

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AURORA SPINE - B521C190090 Catalog Number : C19-009

Device Description : SLAP, HAMMER

Device Class : 1

Duns Number: 079119091

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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