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 K122292
Device Name RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
Applicant
Reliance Medical Systems, LLC
545 WEST 500 SOUTH
SUITE 100
BOUNTIFUL,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
545 WEST 500 SOUTH
SUITE 100
BOUNTIFUL,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/31/2012
Decision Date 10/24/2012
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
-
-