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 Posterior Cervical Screw Placement Guide
510(k) Number K231515
Device Name MySpine Cervical Guides
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Dr., Suite 101
Memphis,  TN  38141
Correspondent Contact Lussier Cristopher
Regulation Number888.3075
Classification Product Code
QSD  
Date Received05/25/2023
Decision Date 12/07/2023
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
-
-