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, nail/blade/plate combination, multiple component
510(k) Number K153377
Device Name Hoffmann LRF (Limb Reconstruction Frame) System
Applicant
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Paul Nelson
Correspondent
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Paul Nelson
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/23/2015
Decision Date 04/11/2016
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
-
-