Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 


New Search Back To Search Results
Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
510(k) Number K052320
Device Name ENCORE CLP OFFSET TOTAL HIP SYSTEM
Applicant
Encore Medical Corporation
11201 Pepper Rd.
Hunt Valley,  MD  21031
Applicant Contact SAM SON
Correspondent
Encore Medical Corporation
11201 Pepper Rd.
Hunt Valley,  MD  21031
Correspondent Contact SAM SON
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received08/25/2005
Decision Date 12/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-