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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (7) Orthopedic Manual Surgical Instrument (LXH) (2) Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1)

Premarket Exempt

No Yes

Clear

8.5mm V-Tap (non-cannulated) - M163011085 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Set Screw - M39240100010 Catalog Number :

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

5.0mm SL Tap (Cannulated) - M735163111050 Catalog Number :

Device Class : 1

Duns Number: 836975784

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Variable Screw, Self-Tapping, 4.0mm x 12mm - M739131064012 Catalog Number :

Device Description : Variable Screw, Self-Tapping, 4.0mm x 12mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Variable Screw, Self-Tapping, 4.0mm x 14mm - M739131064014 Catalog Number :

Device Description : Variable Screw, Self-Tapping, 4.0mm x 14mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Variable Screw, Self-Tapping, 4.0mm x 16mm - M739131064016 Catalog Number :

Device Description : Variable Screw, Self-Tapping, 4.0mm x 16mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Variable Screw, Self-Tapping, 4.0mm x 18mm - M739131064018 Catalog Number :

Device Description : Variable 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

Fixed Screw, Self-Tapping, 4.0mm x 12mm - M739131164012 Catalog Number :

Device Description : Fixed Screw, Self-Tapping, 4.0mm x 12mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Fixed Screw, Self-Tapping, 4.0mm x 14mm - M739131164014 Catalog Number :

Device Description : Fixed Screw, Self-Tapping, 4.0mm x 14mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Fixed Screw, Self-Tapping, 4.0mm x 16mm - M739131164016 Catalog Number :

Device Description : Fixed Screw, Self-Tapping, 4.0mm x 16mm

Device Class : 2

Duns Number: 836975784

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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