• 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, cervical
510(k) Number K172437
Device Name CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Natalia Volosen
Correspondent
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Natalia Volosen
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVD  
Date Received08/11/2017
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-