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 K954208
Device Name OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
Applicant
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Applicant Contact MARTHA C MILLER
Correspondent
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Correspondent Contact MARTHA C MILLER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/07/1995
Decision Date 02/26/1996
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-