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 Thoracolumbosacral Pedicle Screw System
510(k) Number K163096
Device Name GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
Applicant
Gpc Medical Limited
Gpc Sq., M-Block, Dda, Lsc, Vikas Puri
New Delhi,  IN 110018
Applicant Contact VIKAS NARANG
Correspondent
Gpc Medical Limited
Gpc Sq., M-Block, Dda, Lsc, Vikas Puri
New Delhi,  IN 110018
Correspondent Contact VIKAS NARANG
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/04/2016
Decision Date 03/31/2017
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
-
-