FDA 510(k) Application Details - K103208

Device Classification Name	More FDA Info for this Device
510(K) Number	K103208
Device Name	REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
Applicant	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	TEFFANY HUTTO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2010
Decision Date	01/31/2011
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