GMA 2.0 Pedicle Screw System 101-0120-N

GUDID 00810021380322

PRE-BENT ROD, ø5.5 X 120

GRAFTON MEDICAL ALLIANCE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00810021380322
NIH Device Record Key012573f0-5dbd-4a70-9455-901afac78acd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMA 2.0 Pedicle Screw System
Version Model Number101-0120-N
Catalog Number101-0120-N
Company DUNS063381119
Company NameGRAFTON MEDICAL ALLIANCE, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-568-3061
Emailbsanchez@gmasurgical.com

Device Dimensions

Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021380322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810021380322]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-17
Device Publish Date2019-04-25

On-Brand Devices [GMA 2.0 Pedicle Screw System]

00810021380384PRE-BENT ROD, ø5.5 X 180
00810021380377PRE-BENT ROD, ø5.5 X 170
00810021380360PRE-BENT ROD, ø5.5 X 160
00810021380353PRE-BENT ROD, ø5.5 X 150
00810021380346PRE-BENT ROD, ø5.5 X 140
00810021380339PRE-BENT ROD, ø5.5 X 130
00810021380322PRE-BENT ROD, ø5.5 X 120
00810021380315PRE-BENT ROD, ø5.5 X 110
00810021380308PRE-BENT ROD, ø5.5 X 100
00810021380292PRE-BENT ROD, ø5.5 X 90
00810021380285PRE-BENT ROD, ø5.5 X 80
00810021380278PRE-BENT ROD, ø5.5 X 70
00810021380261PRE-BENT ROD, ø5.5 X 60
00810021380254PRE-BENT ROD, ø5.5 X 55
00810021380247PRE-BENT ROD, ø5.5 X 50
00810021380230PRE-BENT ROD, ø5.5 X 45
00810021380223PRE-BENT ROD, ø5.5 X 40
00810021380216PRE-BENT ROD, ø5.5 X 35
00810021380209PRE-BENT ROD, ø5.5 X 30
00810021380193LOCKING SCREW / SET SCREW
00810021380186Polyaxial Pedicle Screw Assembly, 7.5 X 60, Dual Lead, Non-Cannulated
00810021380179Polyaxial Pedicle Screw Assembly, 7.5 X 55, Dual Lead, Non-Cannulated
00810021380162Polyaxial Pedicle Screw Assembly, 7.5 X 50, Dual Lead, Non-Cannulated
00810021380155Polyaxial Pedicle Screw Assembly, 7.5 X 45, Dual Lead, Non-Cannulated
00810021380148Polyaxial Pedicle Screw Assembly, 7.5 X 40, Dual Lead, Non-Cannulated
00810021380131Polyaxial Pedicle Screw Assembly, 7.5 X 35, Dual Lead, Non-Cannulated
00810021380124Polyaxial Pedicle Screw Assembly, 6.5 X 60, Dual Lead, Non-Cannulated
00810021380117Polyaxial Pedicle Screw Assembly, 6.5 X 55, Dual Lead, Non-Cannulated
00810021380100Polyaxial Pedicle Screw Assembly, 6.5 X 50, Dual Lead, Non-Cannulated
00810021380094Polyaxial Pedicle Screw Assembly, 6.5 X 45, Dual Lead, Non-Cannulated
00810021380087Polyaxial Pedicle Screw Assembly, 6.5 X 40, Dual Lead, Non-Cannulated
00810021380070Polyaxial Pedicle Screw Assembly, 6.5 X 35, Dual Lead, Non-Cannulated
00810021380063Polyaxial Pedicle Screw Assembly, 5.5 X 55, Dual Lead, Non-Cannulated
00810021380056Polyaxial Pedicle Screw Assembly, 5.5 X 50, Dual Lead, Non-Cannulated
00810021380049Polyaxial Pedicle Screw Assembly, 5.5 X 45, Dual Lead, Non-Cannulated
00810021380032Polyaxial Pedicle Screw Assembly, 5.5 X 40, Dual Lead, Non-Cannulated
00810021380025Polyaxial Pedicle Screw Assembly, 5.5 X 35, Dual Lead, Non-Cannulated
00810021380018Polyaxial Pedicle Screw Assembly, 5.5 X 30, Dual Lead, Non-Cannulated
00810021380469IMPLANT TRAY
00810021380452INSTRUMENT TRAY #2
00810021380445INSTRUMENT TRAY #1
00810021380438GMA Pedicle Screw Driver Assembly
00810021380421GMA Pedicle Screw Driver Assembly

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