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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K131337
FOIA Releasable 510(k) K131337
Device Name BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
Applicant
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact TOM HAUETER
Correspondent
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact TOM HAUETER
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received05/09/2013
Decision Date 10/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-