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 Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K994217
Device Name BLACKSTONE SPINAL FIXATION SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Applicant Contact ALAN LOMBARDO
Correspondent
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Correspondent Contact ALAN LOMBARDO
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received12/15/1999
Decision Date 02/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-