Variable Screw, Self-Tapping, 4.0mm x 16mm

GUDID M739131064016

Variable Screw, Self-Tapping, 4.0mm x 16mm

CAPTIVA SPINE, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	M739131064016
NIH Device Record Key	822b1824-a359-4be7-9bea-35e86ff05a73
Commercial Distribution Status	In Commercial Distribution
Brand Name	Variable Screw, Self-Tapping, 4.0mm x 16mm
Version Model Number	13106-4016
Company DUNS	836975784
Company Name	CAPTIVA SPINE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M739131064016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141332

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body