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 interlaminal
510(k) Number K150254
Device Name Streamline OCT Occipito-Cervico-Thoracic System
Applicant
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Sarah Pleaugh
Correspondent
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Sarah Pleaugh
Regulation Number888.3050
Classification Product Code
KWP  
Date Received02/03/2015
Decision Date 04/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-