KM-3A Hip System 242852117

GUDID 00880304287679

Biomet Orthopedics, LLC

Acetabular shell
Primary Device ID00880304287679
NIH Device Record Key5eec5b30-84ae-431c-82af-c5265840cd42
Commercial Distribution StatusIn Commercial Distribution
Brand NameKM-3A Hip System
Version Model Number242852117
Catalog Number242852117
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

Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304287679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)


Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [KM-3A Hip System]


© 2019
This site is not affiliated with or endorsed by the FDA.