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 Bone Graft, Cervical
510(k) Number K252219
Device Name Cervical Interbody and VBR Fusion System
Applicant
Sync Surgical
5705 Eastman Dr.
Plano,  TX  75093
Applicant Contact Shawn Culbertson
Correspondent
Djj Consulting, LLC
10301 Lake Ave.
Cleveland,  OH  44102
Correspondent Contact Daniel Johnson
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MQP   PLR  
Date Received07/15/2025
Decision Date 01/14/2026
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
-
-