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, Spinal Pedicle Fixation
510(k) Number K042514
Device Name MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
Applicant
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Applicant Contact DEAN E CIPORKIN
Correspondent
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Correspondent Contact DEAN E CIPORKIN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWQ   MNH  
Date Received09/16/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-