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 Bone Graft, Lumbar
510(k) Number K170119
Device Name Calix Lumbar Spinal Implant System
Applicant
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Applicant Contact Charlene Brumbaugh
Correspondent
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Correspondent Contact Charlene Brumbaugh
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/13/2017
Decision Date 09/29/2017
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
Recalls CDRH Recalls
-
-