SPINAL ELEMENTS, INC.

Address:3115 Melrose Dr Suite 200,CARLSBAD,CA,92010,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 integrated fixation, cervical (OVE) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

No Yes

Clear

SAVANNAH-T - 00840916143565 Catalog Number :

Device Description : STATIC AXIAL HANDLE M8 X 1.25

Device Class : 1

Duns Number: 610712213

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

SAVANNAH-T - 00840916147440 Catalog Number :

Device Description : Letter Opener

Device Class : 1

Duns Number: 610712213

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

OMEGA XP - 00840916148553 Catalog Number :

Device Description : LARGE OMEGA XP® KNOB

Device Class : 1

Duns Number: 610712213

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

OMEGA XP - 00840916148560 Catalog Number :

Device Description : OMEGA XP® AXIAL BREAKDOWN KNOB

Device Class : 1

Duns Number: 610712213

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

OMEGA XP - 00840916148577 Catalog Number :

Device Description : ARTICULATING RAKE W/ RATCHET

Device Class : 1

Duns Number: 610712213

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010408 Catalog Number :

Device Description : Ø4.0 x 10MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010415 Catalog Number :

Device Description : Ø4.0 x 11MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010422 Catalog Number :

Device Description : Ø4.0 x 12MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010439 Catalog Number :

Device Description : Ø4.0 x 13MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010446 Catalog Number :

Device Description : Ø4.0 x 14MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

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