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 K220513
Device Name NITRO Interbody Fusion Cage System Family
Applicant
Ctl Medical Corporation
4550 Excel Pkwy.
Addison,  TX  75001
Applicant Contact Sean Suh
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVE  
Date Received02/22/2022
Decision Date 04/25/2023
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
-
-