F1 MPS Modular Pedicle Screw System 0117-80085

GUDID 00842048105435

Polyaxial Cannulated Screw, CoCr, 8.0mm X 85mm

DEGEN MEDICAL, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00842048105435
NIH Device Record Key9ed1d80b-1e41-4222-b7b0-2408ae693f92
Commercial Distribution StatusIn Commercial Distribution
Brand NameF1 MPS Modular Pedicle Screw System
Version Model Number0117-80085
Catalog Number0117-80085
Company DUNS078812602
Company NameDEGEN MEDICAL, INC.
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 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

Device Dimensions

Length85 Millimeter
Length85 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842048105435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842048105435]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-14

On-Brand Devices [F1 MPS Modular Pedicle Screw System]

00842048121428Rod, Straight, MIS, 5.5 X 480, CoCr
00842048121411Rod, Straight, MIS, 5.5 X 400, CoCr
00842048121404Rod, Straight, MIS, 5.5 X 300, CoCr
00842048121398Rod, Straight, MIS, 5.5 X 200, CoCr
00842048121381Rod, Straight, MIS, 5.5 X 190, CoCr
00842048121374Rod, Straight, MIS, 5.5 X 180, CoCr
00842048121367Rod, Straight, MIS, 5.5 X 170, CoCr
00842048121350Rod, Straight, MIS, 5.5 X 160, CoCr
00842048121343Rod, Straight, MIS, 5.5 X 150, CoCr
00842048121336Rod, Straight, MIS, 5.5 X 140, CoCr
00842048121329Rod, Straight, MIS, 5.5 X 130, CoCr
00842048121312Rod, Straight, MIS, 5.5 X 95, CoCr
00842048121305Rod, Curved, MIS, 5.5 X 120, CoCr
00842048121299Rod, Curved, MIS, 5.5 X 110, CoCr
00842048121282Rod, Curved, MIS, 5.5 X 120, Ti
00842048121275Rod, Curved, MIS, 5.5 X 110, Ti
00842048121268Rod, Straight, MIS, 5.5 X 480, Ti
00842048121251Rod, Straight, MIS, 5.5 X 400, Ti
00842048121244Rod, Straight, MIS, 5.5 X 300, Ti
00842048121237Rod, Straight, MIS, 5.5 X 200, Ti
00842048121220Rod, Straight, MIS, 5.5 X 190, Ti
00842048121213Rod, Straight, MIS, 5.5 X 180, Ti
00842048121206Rod, Straight, MIS, 5.5 X 170, Ti
00842048121190Rod, Straight, MIS, 5.5 X 160, Ti
00842048121183Rod, Straight, MIS, 5.5 X 150, Ti
00842048121176Rod, Straight, MIS, 5.5 X 140, Ti
00842048121169Rod, Straight, MIS, 5.5 X 130, Ti
00842048121152Rod, Straight, MIS, 5.5 X 95, Ti
00842048116981Tulip Head Inserter
00842048116974Rod, Curved, MIS, 5.5 X 100, Ti
00842048116967Rod, Curved, MIS, 5.5 X 90, Ti
00842048116950Rod, Curved, MIS, 5.5 X 85, Ti
00842048116943Rod, Curved, MIS, 5.5 X 80, Ti
00842048116936Rod, Curved, MIS, 5.5 X 75, Ti
00842048116929Rod, Curved, MIS, 5.5 X 70, Ti
00842048116912Rod, Curved, MIS, 5.5 X 65, Ti
00842048116905Rod, Curved, MIS, 5.5 X 60, Ti
00842048116899Rod, Curved, MIS, 5.5 X 55, Ti
00842048116882Rod, Curved, MIS, 5.5 X 50, Ti
00842048116875Rod, Curved, MIS, 5.5 X 45, Ti
00842048116868Rod, Curved, MIS, 5.5 X 40, Ti
00842048116851Rod, Curved, MIS, 5.5 X 35, Ti
00842048116844Rod, Curved, MIS, 5.5 X 30, Ti
00842048116837Rod, Straight, MIS, 5.5 X 120, Ti
00842048116820Rod, Straight, MIS, 5.5 X 110, Ti
00842048116813Rod, Straight, MIS, 5.5 X 100, Ti
00842048116806Rod, Straight, MIS, 5.5 X 90, Ti
00842048116790Rod, Straight, MIS, 5.5 X 85, Ti
00842048116783Rod, Straight, MIS, 5.5 X 80, Ti
00842048116776Rod, Straight, MIS, 5.5 X 75, Ti
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