• 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 K192026
Device Name Peridot Intervertebral body fusion System
Applicant
GBS Commonwealth Co., Ltd.
C-309, Woolim Lion's Valley, 168, Gasan digital 1-ro
geumcheon-gu,  KR 08507
Applicant Contact jimmy kim
Correspondent
GBS Commonwealth Co., Ltd.
C-309, Woolim Lion's Valley, 168, Gasan digital 1-ro
geumcheon-gu,  KR 08507
Correspondent Contact jimmy kim
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/29/2019
Decision Date 11/26/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-