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 Body Graft Containment Device
510(k) Number K230927
Device Name OptiMesh Multiplanar Expandable Interbody Fusion System
Applicant
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Applicant Contact Andrew Adams
Correspondent
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Correspondent Contact Andrew Adams
Regulation Number888.3085
Classification Product Code
OQB  
Date Received04/03/2023
Decision Date 11/01/2023
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
-
-