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510(k) K051844

Device
EQUATOR PLUS ACETABULAR CUP SYSTEM
Applicant
PORTLAND ORTHOPAEDICS PTY. LTD.
510(k) number
K051844
Product code
MAY  
Decision
Substantially Equivalent (SESE)
Decision date
2005-10-07
Date received
2005-07-07
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELAINE DUNCAN
Address
P.O. Box 560 Stillwater MN US 55082 55082

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
K090103100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALLBiomet, Inc.2009-02-11

Legacy Summary#

summary

FDA Review#

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