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510(k) K982398

Device
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
Applicant
BIOMET, INC.
510(k) number
K982398
Product code
JDC  
Decision
Substantially Equivalent (SESE)
Decision date
1998-08-11
Date received
1998-07-10
Regulation
888.3150
Classification name
Prosthesis, Elbow, Constrained, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FRED MCCLURE
Address
Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181362TEMA Elbow SystemLima Corporate S.P.A.2019-02-16
K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc.2019-01-28
K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp2016-02-03
K150501Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc.2015-04-23
K123862ZIMMER NEXEL TOTAL ELBOWZimmer, Inc.2013-03-12
K090473DISCOVERY ELBOW - X-SMALLBiomet Manufacturing Corp2009-03-25
K060696ACCLAIM TOTAL ELBOW SYSTEMDePuy Orthopaedics, Inc.2006-04-14
K053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESZimmer, Inc.2005-12-09
K051975POROUS COATED DISCOVERY ELBOWBiomet, Inc.2005-09-06
K042664LPS UPPER EXTREMITYDepuy, Inc.2004-12-08
K040389COONRAD/MORREY ELBOW CEMENT RESTRICTORZimmer, Inc.2004-05-17
K033280DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEMBiomet, Inc.2003-12-19
K013042DISCOVERY ELBOWBiomet Orthopedics, Inc.2001-10-10
K003253BIOMET'S MINIMALLY CONSTRAINED ELBOWBiomet, Inc.2001-01-12
K000003TORNIER TOTAL ELBOW PROSTHESISTornier2000-10-02

Legacy Summary#

summary

FDA Review#

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