SPINAL ELEMENTS, INC.

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 Bone Graft, Lumbar (MAX) (7) Orthopedic Manual Surgical Instrument (LXH) (2) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

No Yes

Clear

LUCENT XP - 00840606100014 Catalog Number :

Device Description : Lucent XP® Offset Inserter

Device Class : 1

Duns Number: 610712213

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100021 Catalog Number :

Device Description : Lucent XP® 12mm Offset Inserter

Device Class : 1

Duns Number: 610712213

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

OVERWATCH - 00840606100038 Catalog Number :

Device Description : OVERWATCH® ILIAC DIA. 7.5 X 60MM POLYAXIAL SCREW

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

LUCENT XP - 00840606100045 Catalog Number :

Device Description : LUCENT XP® 10MM X 24MM X 8MM 5°- 10°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100052 Catalog Number :

Device Description : LUCENT XP® 10MM X 24MM X 9MM 5°- 10°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100069 Catalog Number :

Device Description : LUCENT XP® 10MM X 24MM X 10MM 5°- 10°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100076 Catalog Number :

Device Description : LUCENT XP® 10MM X 24MM X 11MM 5°- 10°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100083 Catalog Number :

Device Description : LUCENT XP® 10MM X 24MM X 12MM 5°- 10°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT XP - 00840606100090 Catalog Number :

Device Description : LUCENT XP® 10MM X 32MM X 8MM 10°- 15°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

LUCENT - 00840606100106 Catalog Number :

Device Description : Lucent XP® 10 x 32 x 9mm, 10-15°

Device Class : 2

Duns Number: 610712213

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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