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 Staple, Fixation, Bone
510(k) Number K153129
Device Name dynaMX Tabbed Staple
Applicant
MX Orthopedics, Corp.
1 Broadway, 14th Floor
Cambridge,  MA  02142
Applicant Contact Howard L. Schrayer
Correspondent
MX Orthopedics, Corp.
1 Broadway, 14th Floor
Cambridge,  MA  02142
Correspondent Contact Howard L. Schrayer
Regulation Number888.3030
Classification Product Code
JDR  
Date Received10/30/2015
Decision Date 01/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-