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510(k) K042841

Device
M2A/C2A ACETABULAR SYSTEM
Applicant
BIOMET, INC.
510(k) number
K042841
Product code
JDL  
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-21
Date received
2004-10-14
Regulation
888.3320
Classification name
Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PATRICIA S ANDBORN BERES
Address
56 E. Bell Dr. P.O. Box 587 Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.2008-08-07
K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyinc2007-07-11
K061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyinc2006-12-06
K051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyinc2005-08-22
K051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyinc2005-08-19
K041586PROFEMUR S HIP STEMWrightmedicaltechnologyinc2004-07-09
K041114PROFEMUR TAPERED HIP STEMWrightmedicaltechnologyinc2004-05-28
K004043METAL TRANSCEND ARTICULATION SYSTEMWrightmedicaltechnologyinc2001-07-13
K950542METAL BACKED ACETABULAR COMPONENTEncore Orthopedics, Inc.1995-05-25
K944769P.F.C. APICAL PLUGJohnson & Johnson Professionals, Inc.1994-12-08
K942809ACETABULAR DOME HOLE PLUGSOsteonics Corp.1994-09-20
K931676S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUGJoint Medical Products Corp.1994-05-18
K934440PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLESHowmedica Corp.1994-02-22
K930833PCA(R) SOLID BACK ACETABULA SHELLHowmedica Corp.1994-02-22
K935669SYRIGENE PRE-FILLED SYRINGERegulatory & Marketing Services, Inc.1994-02-18

Legacy Summary#

summary

FDA Review#

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