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 System
510(k) Number K221307
Device Name Edge Upper Cervical System
Applicant
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received05/05/2022
Decision Date 07/10/2023
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
-
-