• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K040354
Device Name METAL/METAL HIP SYSTEM
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Applicant Contact debbie de los santos
Correspondent
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Correspodent Contact debbie de los santos
Regulation Number888.3330
Classification Product Code
KWA  
Date Received02/12/2004
Decision Date 11/04/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-