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 Integrated Fixation, Cervical
510(k) Number K161081
Device Name SeaSpine Shoreline ACS - Anterior Cervical Standalone System
Applicant
SEASPINE ORTHOPEDICS CORPORATION
5770 ARMADA DRIVE
CARLSBAD,  CA  92008
Applicant Contact Michelle Willis
Correspondent
SEASPINE ORTHOPEDICS CORPORATION
5770 ARMADA DRIVE
CARLSBAD,  CA  92008
Correspondent Contact Jenny Fam
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/18/2016
Decision Date 09/14/2016
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
-
-