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, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K040225
Device Name OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
Applicant
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Applicant Contact SAM SON
Correspondent
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Correspondent Contact SAM SON
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received02/02/2004
Decision Date 05/06/2004
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
-
-