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 Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K233191
Device Name TotalTi ACDF by SAGICO
Applicant
Spinal Analytics & Geometrical Implant Co, LLC
2189 W.Busch Blvd.
Tampa,  FL  33612
Applicant Contact James J. Gibson
Correspondent
Spinal Analytics & Geometrical Implant Co, LLC
2189 W.Busch Blvd.
Tampa,  FL  33612
Correspondent Contact James J. Gibson
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/28/2023
Decision Date 11/21/2023
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
-
-