FDA 510(k) Application Details - K083469

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K083469
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	METASURG 16350 PARK TEN PL., SUITE 101 HOUSTON, TX 77084 US Other 510(k) Applications for this Company
Contact	MARK MYERS 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	11/24/2008
Decision Date	02/13/2009
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