AGC KNEE SYSTEM 155588

GUDID 00880304246621

Biomet Orthopedics, LLC

Uncoated knee tibia prosthesis, metallic
Primary Device ID00880304246621
NIH Device Record Keyd572f702-5ae5-4c51-8ece-0854d6f8e31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGC KNEE SYSTEM
Version Model Number155588
Catalog Number155588
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304246621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-10-24

On-Brand Devices [AGC KNEE SYSTEM]

00880304248793159259
00880304248786159258
00880304248762159253
00880304248755159252
00880304248731159247
00880304248724159246
00880304248700159241
00880304248694159240
00880304248656159231
00880304248649159230
00880304248632159229
00880304248625159228
00880304248601159226
00880304248595159225
00880304248588159224
00880304248571159223
00880304248564159222
00880304248533159219
00880304248526159218
00880304248519159217
00880304248502159216
00880304248496159215
00880304248472159213
00880304248465159212
00880304248458159211
00880304248441159210
00880304248434159209
00880304248427159208
00880304248397159205
00880304248380159204
00880304248373159203
00880304248366159202
00880304248359159201
00880304248342159200
00880304247475155758
00880304247468155754
00880304247451155752
00880304247444155750
00880304247413155738
00880304247406155734
00880304247383155732
00880304247369155730
00880304247352155728
00880304247154155670
00880304246980155628
00880304246898155607
00880304246621155588
00880304246560155584
00880304246546155583
00880304246492155580

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