• 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 neurosurgical nerve locator
510(k) Number K191723
Device Name ATEC IOM Accessory Instruments
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
carlsbad,  CA  92008
Applicant Contact ruby zheng
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
carlsbad,  CA  92008
Correspondent Contact ruby zheng
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received06/27/2019
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-