FDA 510(k) Application Details - K111068

Device Classification Name	Prosthesis, Wrist, Carpal Trapezium   More FDA Info for this Device
510(K) Number	K111068
Device Name	Prosthesis, Wrist, Carpal Trapezium
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, ESQ Other 510(k) Applications for this Contact
Regulation Number	888.3770   More FDA Info for this Regulation Number
Classification Product Code	KYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2011
Decision Date	12/30/2011
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