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) (10)

Premarket Exempt

No Yes

Clear

Mosaic - 08406061010552 Catalog Number :

Device Description : Ø4.5 x 16MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010569 Catalog Number :

Device Description : Ø4.5 x 17MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010576 Catalog Number :

Device Description : Ø4.5 x 18MM VARIABLE-ANGLE SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010583 Catalog Number :

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

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010590 Catalog Number :

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

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010606 Catalog Number :

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

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010613 Catalog Number :

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

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010620 Catalog Number :

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

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010637 Catalog Number :

Device Description : Ø4.0 x 15MM VARIABLE-ANGLE, SELF-DRILLING SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

Mosaic - 08406061010644 Catalog Number :

Device Description : Ø4.0 x 16MM VARIABLE-ANGLE, SELF-DRILLING SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

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