• 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 | 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/polymer, porous uncemented
510(k) Number K122504
Device Name FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
Original Applicant
UNITED ORTHOPEDIC CORPORATION
no 57, park ave 2,
science park
hsinchu,  TW 300
Original Contact fang-yuan ho
Regulation Number888.3358
Classification Product Code
LPH  
Date Received08/16/2012
Decision Date 10/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-