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 Driver, Wire, And Bone Drill, Manual
510(k) Number K230276
Device Name TECHFIT DISRP® System
Applicant
Techfit Digital Surgery
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Applicant Contact Angela María Lema-Pérez
Correspondent
Techfit Digital Surgery
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Correspondent Contact Angela María Lema-Pérez
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received02/01/2023
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-