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 Plate, Fixation, Bone
510(k) Number K213895
Device Name Distal Humerus Plating System
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez
Correspondent
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/14/2021
Decision Date 01/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-