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 K896397
Device Name S-ROM(TM)/NOILES(TM) MARK 5 KNEE
Applicant
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Applicant Contact DEBRA L BING
Correspondent
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Correspondent Contact DEBRA L BING
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/07/1989
Decision Date 02/22/1990
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
-
-