FDA 510(k) Application Details - K113752

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K113752
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 MEMPHIS, TN 38119 US Other 510(k) Applications for this Company
Contact	LOUISE FOCHT Other 510(k) Applications for this Contact
Regulation Number	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2011
Decision Date	02/06/2012
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