CAPTIVA SPINE, INC.

Address:967 N HIGHWAY A1A ALT STE 1,Jupiter,FL,33477,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) (9) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (1)

Premarket Exempt

No Yes

Clear

Fixed Screw, Self-Tapping, 4.0mm x 18mm - M739131164018 Catalog Number :

Device Description : Fixed Screw, Self-Tapping, 4.0mm x 18mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

11mm Drill Bit Spade Tip - M739133400011 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SmartLOX Cervical Plate System - M7391334000110 Catalog Number :

Device Description : 11mm Drill Bit Spade Tip

Device Class : 1

Duns Number: 836975784

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

12mm Drill Bit Spade Tip - M739133400012 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SmartLOX Cervical Plate System - M7391334000120 Catalog Number :

Device Description : 12mm Drill Bit Spade Tip

Device Class : 1

Duns Number: 836975784

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

13mm Drill Bit Spade Tip - M739133400013 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SmartLOX Cervical Plate System - M7391334000130 Catalog Number :

Device Description : 13mm Drill Bit Spade Tip

Device Class : 1

Duns Number: 836975784

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

14mm Drill Bit Spade Tip - M739133400014 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SmartLOX Cervical Plate System - M7391334000140 Catalog Number :

Device Description : 14mm Drill Bit Spade Tip

Device Class : 1

Duns Number: 836975784

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

15mm Drill Bit Spade Tip - M739133400015 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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