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 Arthroscope
510(k) Number K263208
Device Name Vantage Lumbar Decompression Kit
Applicant
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Richard Sharp
Correspondent
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Richard Sharp
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received09/14/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-