Polaris 5.5 Spinal Fixation System 14-578820R

GUDID 03662663170529

5.5 TI 10.5X20MM TRANS REDUC

Highridge Medical, LLC

Spinal bone screw, non-bioabsorbable
Primary Device ID03662663170529
NIH Device Record Keyd9a7a56a-44f8-4a91-9c98-13fd2d417144
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolaris 5.5 Spinal Fixation System
Version Model Number14-578820R
Catalog Number14-578820R
Company DUNS119260394
Company NameHighridge Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663170529 [Primary]

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662663170529]

Moist Heat or Steam Sterilization


[03662663170529]

Moist Heat or Steam Sterilization


[03662663170529]

Moist Heat or Steam Sterilization


[03662663170529]

Moist Heat or Steam Sterilization


[03662663170529]

Moist Heat or Steam Sterilization


[03662663170529]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-21
Device Publish Date2025-11-13

On-Brand Devices [Polaris 5.5 Spinal Fixation System]

036626631708405.5 TI 10.5X100MM TRANS REDUC
036626631708335.5 TI 10.5 X100MM TRANSLATION
036626631708195.5 TI 10.5 X 95MM TRANSLATION
036626631707965.5 TI 10.5 X 90MM TRANSLATION
036626631707725.5 TI 10.5 X 85MM TRANSLATION
036626631707585.5 TI 10.5 X 80MM TRANSLATION
036626631707345.5 TI 10.5 X 75MM TRANSLATION
036626631707105.5 TI 10.5 X 70MM TRANSLATION
036626631706975.5 TI 10.5 X 65MM TRANSLATION
036626631706735.5 TI 10.5 X 60MM TRANSLATION
036626631706595.5 TI 10.5 X 55MM TRANSLATION
036626631706355.5 TI 10.5 X 50MM TRANSLATION
036626631706285.5 TI 10.5X45MM TRANS REDUC
036626631706115.5 TI 10.5 X 45MM TRANSLATION
036626631706045.5 TI 10.5X40MM TRANS REDUC
036626631705985.5 TI 10.5 X 40MM TRANSLATION
036626631705815.5 TI 10.5X35MM TRANS REDUC
036626631705745.5 TI 10.5 X 35MM TRANSLATION
036626631705675.5 TI 10.5X30MM TRANS REDUC
036626631705505.5 TI 10.5 X 30MM TRANSLATION
036626631705435.5 TI 10.5X25MM TRANS REDUC
036626631705365.5 TI 10.5 X 25MM TRANSLATION
036626631705295.5 TI 10.5X20MM TRANS REDUC
036626631705125.5 TI 10.5 X 20MM TRANSLATION
036626631705055.5 TI 10.5X150MM TRANS REDUC
036626631704995.5 TI 10.5 X150MM TRANSLATION
036626631704825.5 TI 10.5X145MM TRANS REDUC
036626631704755.5 TI 10.5 X145MM TRANSLATION
036626631704685.5 TI 10.5X140MM TRANS REDUC
036626631704515.5 TI 10.5 X140MM TRANSLATION
036626631704445.5 TI 10.5X135MM TRANS REDUC
036626631704375.5 TI 10.5 X135MM TRANSLATION
036626631704205.5 TI 10.5X130MM TRANS REDUC
036626631704135.5 TI 10.5 X130MM TRANSLATION
036626631704065.5 TI 10.5X125MM TRANS REDUC
036626631703905.5 TI 10.5 X125MM TRANSLATION
036626631703835.5 TI 10.5X120MM TRANS REDUC
036626631703765.5 TI 10.5 X120MM TRANSLATION
036626631703695.5 TI 10.5X115MM TRANS REDUC
036626631703525.5 TI 10.5 X115MM TRANSLATION
036626631703455.5 TI 10.5X110MM TRANS REDUC
036626631703385.5 TI 10.5 X110MM TRANSLATION
036626631703215.5 TI 10.5X105MM TRANS REDUC
036626631703145.5 TI 10.5 X105MM TRANSLATION
036626631702915.5 TI 9.5 X 100MM TRANSLATION
036626631702845.5 TI 9.5X95MM TRANS REDUC
036626631702775.5 TI 9.5 X 95MM TRANSLATION
036626631702605.5 TI 9.5X90MM TRANS REDUC
036626631702535.5 TI 9.5 X 90MM TRANSLATION
036626631702465.5 TI 9.5X85MM TRANS REDUC

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