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510(k) K090103

Device
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
Applicant
BIOMET, INC.
510(k) number
K090103
Product code
MAY  
Decision
Substantially Equivalent (SESE)
Decision date
2009-02-11
Date received
2009-01-15
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BECKY EARL
Address
56 E. Bell Dr. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123604ABG III MONOLITHIC HIP STEMHowmedica Osteonics Corp.2013-08-16
K110807ABG II MONOLITHIC HIP STEMStryker Corp.2011-05-25
K051844EQUATOR PLUS ACETABULAR CUP SYSTEMPortland Orthopaedics Pty. , Ltd.2005-10-07

Legacy Summary#

summary

FDA Review#

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