SELEX / M2A-MAGNUM HIP SYSTEM S661140

GUDID 00880304477841

Biomet Orthopedics, LLC

Metallic femoral head prosthesis
Primary Device ID00880304477841
NIH Device Record Key1269f6f5-5da9-46e0-b5f6-6a4eb635f629
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELEX / M2A-MAGNUM HIP SYSTEM
Version Model NumberS661140
Catalog NumberS661140
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
GS100880304477841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-18

On-Brand Devices [SELEX / M2A-MAGNUM HIP SYSTEM]

00880304477841S661140
00880304477681S991140
00880304477674S061140
00880304477650S331140
00880304477643S031140
00880304430822S001140

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