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 K093235
Device Name RINGLOC + HYBRID ACETABULAR SYSTEM
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw,  IN  46581 -0587
Applicant Contact gary baker
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw,  IN  46581 -0587
Correspondent Contact gary baker
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LPH   LZO  
Date Received10/15/2009
Decision Date 04/30/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-