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

Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

No Yes

Clear

MERCURY - 00840606100311 Catalog Number :

Device Description : L Rod, 75mm

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100328 Catalog Number :

Device Description : Parallel Closed Rod to Rod Connector

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100335 Catalog Number :

Device Description : Axial Rod to Rod Connector

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100342 Catalog Number :

Device Description : Parallel Closed Rod to Rod Connector

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100359 Catalog Number :

Device Description : Left L-Connector

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100366 Catalog Number :

Device Description : Right L Connector

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100373 Catalog Number :

Device Description : Dia. 5.5x30mm Straight CoCr Rod

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100380 Catalog Number :

Device Description : Dia. 5.5x35mm Straight CoCr Rod

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100397 Catalog Number :

Device Description : Dia. 5.5x40mm Straight CoCr Rod

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

MERCURY - 00840606100403 Catalog Number :

Device Description : Dia. 5.5x45mm Straight CoCr Rod

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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