FDA.reportPublic FDA data

510(k) K123604

Device
ABG III MONOLITHIC HIP STEM
Applicant
HOWMEDICA OSTEONICS CORP
510(k) number
K123604
Product code
MAY  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-16
Date received
2012-11-21
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
COLLEEN BURDEL
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

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
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
K051844EQUATOR PLUS ACETABULAR CUP SYSTEMPortland Orthopaedics Pty. , Ltd.2005-10-07

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases