Glenoid Reconstruction System

GUDID 07630345710505

GRS central screw - L20

Medacta International SA

Shoulder prosthesis screw
Primary Device ID07630345710505
NIH Device Record Keyc3c161ac-67b3-4e12-a23d-8f1641f83a37
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlenoid Reconstruction System
Version Model Number04.01.0321
Company DUNS488227125
Company NameMedacta International SA
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630345710505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-06
Device Publish Date2022-11-28

On-Brand Devices [Glenoid Reconstruction System]

07630345710529GRS central screw - L30
07630345710512GRS central screw - L25
07630345710505GRS central screw - L20
07630345710499GRS central screw - L15
07630345710406GRS baseplate - Ø27x30 +6mm
07630345710390GRS baseplate - Ø27x30 +3mm
07630345710383GRS baseplate - Ø27x30
07630345710376GRS baseplate - Ø27x20 +6mm
07630345710369GRS baseplate - Ø27x20 +3mm
07630345710352GRS baseplate - Ø27x20
07630345710345GRS baseplate - Ø24.5x30 +6mm
07630345710338GRS baseplate - Ø24.5x30 +3mm
07630345710321GRS baseplate - Ø24.5x30
07630345710314GRS baseplate - Ø24.5x20 +6mm
07630345710307GRS baseplate - Ø24.5x20 +3mm
07630345710291GRS baseplate - Ø24.5x20
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