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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K892644
Device Name BIOLOX CERAMIC BALL
Applicant
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Applicant Contact SYLVIA K PIERPOINT
Correspondent
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Correspondent Contact SYLVIA K PIERPOINT
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/12/1989
Decision Date 10/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-