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 K925242
Device Name APOLLO(TM) KNEE SYSTEM
Applicant
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/16/1992
Decision Date 06/04/1993
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
-
-