• 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 K003250
Device Name FMP METAL/METAL ACETABULAR INSERT
Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin,  TX  78758
Applicant Contact debbie de los santos
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin,  TX  78758
Correspodent Contact debbie de los santos
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/17/2000
Decision Date 01/25/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-