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 K193305
Device Name DynaClip Bone Staple
Applicant
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Applicant Contact Jack Griffis
Correspondent
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Correspondent Contact Jack Griffis
Regulation Number888.3030
Classification Product Code
JDR  
Date Received11/29/2019
Decision Date 04/23/2020
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
-
-