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 Orthosis, Spinal Pedicle Fixation
510(k) Number K141253
Device Name NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
Applicant
New Era Orthopaedics, LLC
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
New Era Orthopaedics, LLC
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received05/14/2014
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-