Anatomical Shoulder™ Reverse

GUDID 00889024286092

AS Inverse Humerus Cup, +20 retro

Zimmer GmbH

Total reverse shoulder prosthesis
Primary Device ID00889024286092
NIH Device Record Key7bae94b0-bf88-49c8-9631-54b817d4f238
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomical Shoulder™ Reverse
Version Model Number01.04223.120
Company DUNS488133448
Company NameZimmer GmbH
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

Angle20 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024286092 [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 Number3
Public Version Date2019-10-14
Device Publish Date2017-07-27

On-Brand Devices [Anatomical Shoulder™ Reverse]

00889024286214AS Inverse Humeral PE-Inlay 40-6
00889024286207AS Inverse Humeral PE-Inlay 40-3
00889024286191AS Inverse Humeral PE-Inlay 40-0
00889024286184AS Inverse Humeral PE-Inlay 36-6
00889024286177AS Inverse Humeral PE-Inlay 36-3
00889024286160AS Inverse Humeral PE-Inlay 36-0
00889024286153AS Inverse Glenoid head 40
00889024286146AS Inverse Glenoid head 36
00889024286139AS Inverse Glenoid fixation
00889024286122AS Inverse Humeral Cup, off center +9
00889024286115AS Inverse Humeral Cup, standard +9
00889024286108AS Inverse Humeral Cup, -20 retro
00889024286092AS Inverse Humerus Cup, +20 retro
00889024286085AS Inverse Humeral Cup, -10 retro
00889024286078Anatomical Shoulder™ Reverse, humeral cup, +10°, retro
00889024286061AS Inverse Humeral Cup, off center
00889024286054AS Inverse Humeral Cup, standard

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.