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 K941306
Device Name FOUNDATION KNEE AUGMENTATION BLOCKS
Applicant
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Applicant Contact J.D. WEBB
Correspondent
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Correspondent Contact J.D. WEBB
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/17/1994
Decision Date 02/08/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-