SOLANAS Posterior Stabilization System

GUDID 00844856006713

Polyaxial Posterior Thoracic Screw, 3.5mm X 38mm

ALPHATEC SPINE, INC.

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Primary Device ID	00844856006713
NIH Device Record Key	b4e258c9-a937-4723-bfd7-71da52e6d31d
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOLANAS Posterior Stabilization System
Version Model Number	63035-38
Company DUNS	602465783
Company Name	ALPHATEC SPINE, INC.
Device Count	1
DM Exempt	true
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

Customer Support Contacts

Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com

Device Dimensions

Length	38 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856006713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052201
Premarket Notification: K191185

FDA Product Code

KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL