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 Implant, Fixation Device, Spinal
510(k) Number K897141
Device Name SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
Applicant
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Applicant Contact ABRAHAM GLASSER
Correspondent
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Correspondent Contact ABRAHAM GLASSER
Regulation Number888.3060
Classification Product Code
JDN  
Date Received12/27/1989
Decision Date 06/21/1990
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
Predetermined Change
Control Plan Authorized		 No
-
-