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, Lumbar
510(k) Number K211740
Device Name DualX
Applicant
Amplify Surgical, Inc.
9272 Jeronimo Rd. Suite 107b
Irvine,  CA  92618
Applicant Contact Andy Choi
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/07/2021
Decision Date 09/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-