FDA 510(k) Application Details - K153208

Device Classification Name	More FDA Info for this Device
510(K) Number	K153208
Device Name	Internal Joint Stabilizer - Elbow
Applicant	SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 MIAMI, FL 33176 US Other 510(k) Applications for this Company
Contact	Ana M Escagedo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2015
Decision Date	12/31/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review