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510(k) K063414

Device
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
Applicant
Encore Medical L.P.
510(k) number
K063414
Product code
KWA
Decision
Substantially Equivalent (SESE)
Decision date
2006-12-12
Date received
2006-11-13
Regulation
888.3330
Classification name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
3
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TEFFANY HUTTO
Address
9800 Metric Blvd. Austin TX US 78758 78758

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyinc2012-10-11
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K113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.2012-05-18
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K111910GLADIATOR HIP STEMWrightmedicaltechnologyinc2011-10-14
K110836CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbH2011-10-07
K110400TAPERLOC COMPLETE MICROPLASTY STEMBiomet Manufacturing Corp2011-09-30
K111699PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEMWrightmedicaltechnologyinc2011-08-19
K111698PROFEMUR(R) E CEMENTLESS HIP STEMWrightmedicaltechnologyinc2011-08-19
K110399GLADIATOR PLASMA CLASSIC HIP STEMWrightmedicaltechnologyinc2011-05-10
K110029CONSERVE BIO FOAM SHELLWrightmedicaltechnologyinc2011-04-19
K103755TAPERLOC COMPLETE, SIZE 5 AND 6Biomet Manufacturing Corp2011-01-21