F1 MPS Modular Pedicle Screw System 0104-55500

GUDID 00842048100218

Straight Ti Rod, 5.5 X 500

DEGEN MEDICAL, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00842048100218
NIH Device Record Key485ca6f9-df4f-4601-a9db-64dc7b053e60
Commercial Distribution StatusIn Commercial Distribution
Brand NameF1 MPS Modular Pedicle Screw System
Version Model Number0104-55500
Catalog Number0104-55500
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

Length500 Millimeter
Length500 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842048100218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842048100218]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.