HemiCAPGRS® G203-2015-W

GUDID M528G2032015W0

ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD

ARTHROSURFACE INCORPORATED

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device IDM528G2032015W0
NIH Device Record Keyfb59936b-1aa0-4cd3-8c24-2a02b7e927de
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemiCAPGRS®
Version Model NumberG203-2015-W
Catalog NumberG203-2015-W
Company DUNS144666109
Company NameARTHROSURFACE INCORPORATED
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

Customer Support Contacts

Phone508-520-3003
Emailcontact@arthrosurface.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM528G2032015W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2015-09-15

On-Brand Devices [HemiCAPGRS®]

M528G2032520W0ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD
M528G2032520A0ARTICULAR, 20 X 25MM IMPLANT, GLENOID 53/50 HEAD
M528G2032515W0ARTICULAR, 20 x 25mm IMPLANT, GLENOID 58/55 HEAD
M528G2032515A0ARTICULAR, 20 x 25mm IMPLANT, GLENOID 58/55 HEAD
M528G2032015W0ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD
M528G2032015A0ARTICULAR, 19 x 20mm IMPLANT, GLENOID 53/50 HEAD
M528G2032010W0ARTICULAR, 19 x 20mm IMPLANT, GLENOID 58/55 HEAD
M528G2032010A0ARTICULAR, 19 x 20mm IMPLANT, GLENOID 58/55 HEAD
M528G00714000Glenoid Pin Kit
M528G00002000Glenoid Universal Delivery Kit-Twin Glenoid
M528G00001000Glenoid Universal Delivery Kit

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