SOLANAS Posterior Stabilization System

GUDID 00844856007260

Polyaxial Posterior Smooth Shank Thoracic Screw, 3.5mm X 24mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system
Primary Device ID00844856007260
NIH Device Record Keyd1ef3068-d498-4f5b-98c4-b39feb52d2b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLANAS Posterior Stabilization System
Version Model Number63135-24
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter
Length24 Millimeter
Outer Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856007260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


[00844856007260]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

On-Brand Devices [SOLANAS Posterior Stabilization System]

00190376065250CoCr 2 Posterior Cervical Rod, 3.3mm X 240mm
00190376065243CoCr 2 Posterior Cervical Rod, 3.3mm X 235mm
00190376065236CoCr 2 Posterior Cervical Rod, 3.3mm X 230mm
00190376065229CoCr 2 Posterior Cervical Rod, 3.3mm X 225mm
00190376065212CoCr 2 Posterior Cervical Rod, 3.3mm X 220mm
00190376065205CoCr 2 Posterior Cervical Rod, 3.3mm X 215mm
00190376065199CoCr 2 Posterior Cervical Rod, 3.3mm X 210mm
00190376065182CoCr 2 Posterior Cervical Rod, 3.3mm X 205mm
00190376065175CoCr 2 Posterior Cervical Rod, 3.3mm X 200mm
00190376065168CoCr 2 Posterior Cervical Rod, 3.3mm X 195mm
00190376065151CoCr 2 Posterior Cervical Rod, 3.3mm X 190mm
00190376065144CoCr 2 Posterior Cervical Rod, 3.3mm X 185mm
00190376065137CoCr 2 Posterior Cervical Rod, 3.3mm X 180mm
00190376065120CoCr 2 Posterior Cervical Rod, 3.3mm X 175mm
00190376065113CoCr 2 Posterior Cervical Rod, 3.3mm X 170mm
00190376065106CoCr 2 Posterior Cervical Rod, 3.3mm X 165mm
00190376065090CoCr 2 Posterior Cervical Rod, 3.3mm X 160mm
00190376065083CoCr 2 Posterior Cervical Rod, 3.3mm X 155mm
00190376065076CoCr 2 Posterior Cervical Rod, 3.3mm X 150mm
00190376065069CoCr 2 Posterior Cervical Rod, 3.3mm X 145mm
00190376065052CoCr 2 Posterior Cervical Rod, 3.3mm X 140mm
00190376065045CoCr 2 Posterior Cervical Rod, 3.3mm X 135mm
00190376065038CoCr 2 Posterior Cervical Rod, 3.3mm X 130mm
00190376065021CoCr 2 Posterior Cervical Rod, 3.3mm X 125mm
00190376065014CoCr 2 Posterior Cervical Rod, 3.3mm X 120mm
00190376065007CoCr 2 Posterior Cervical Rod, 3.3mm X 115mm
00190376064994CoCr 2 Posterior Cervical Rod, 3.3mm X 110mm
00190376064987CoCr 2 Posterior Cervical Rod, 3.3mm X 105mm
00190376064970CoCr 2 Posterior Cervical Rod, 3.3mm X 100mm
00190376064963CoCr 2 Posterior Cervical Rod, 3.3mm X 95mm
00190376064956CoCr 2 Posterior Cervical Rod, 3.3mm X 90mm
00190376064949CoCr 2 Posterior Cervical Rod, 3.3mm X 85mm
00190376064932CoCr 2 Posterior Cervical Rod, 3.3mm X 80mm
00190376064925CoCr 2 Posterior Cervical Rod, 3.3mm X 75mm
00190376064918CoCr 2 Posterior Cervical Rod, 3.3mm X 70mm
00190376064901CoCr 2 Posterior Cervical Rod, 3.3mm X 65mm
00190376064895CoCr 2 Posterior Cervical Rod, 3.3mm X 60mm
00190376064888CoCr 2 Posterior Cervical Rod, 3.3mm X 55mm
00190376064871CoCr 2 Posterior Cervical Rod, 3.3mm X 50mm
00190376064864CoCr 2 Posterior Cervical Rod, 3.3mm X 45mm
00190376064857CoCr 2 Posterior Cervical Rod, 3.3mm X 40mm
00190376064840CoCr 2 Posterior Cervical Rod, 3.3mm X 35mm
00190376064833CoCr 2 Posterior Cervical Rod, 3.3mm X 30mm
00190376064826CoCr 2 Posterior Cervical Rod, 3.3mm X 25mm
00190376064819CoCr 2 Posterior Cervical Rod, 3.3mm X 20mm
00190376062921CoCr Posterior Cervical Rod, 3.3mm X 240mm
00190376062914CoCr Posterior Cervical Rod, 3.3mm X 235mm
00190376062907CoCr Posterior Cervical Rod, 3.3mm X 230mm
00190376062891CoCr Posterior Cervical Rod, 3.3mm X 225mm
00190376062884CoCr Posterior Cervical Rod, 3.3mm X 220mm

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