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 Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K183073
Device Name SMG Anterior Cervical Plate System
Applicant
Sapphire Medical Group
32565 B Golden Lantern St.
Suite 113
Dana Point,  CA  92629
Applicant Contact Anthony Ruggiero
Correspondent
Consultant
32565 B Golden Lantern St.
Suite 113
Dana Point,  CA  92629
Correspondent Contact Anthony Ruggiero
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/05/2018
Decision Date 02/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-