FDA 510(k) Application Details - K981194

Device Classification Name	Prosthesis, Toe, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K981194
Device Name	Prosthesis, Toe, Constrained, Polymer
Applicant	NEXA ORTHOPEDICS, INC. 9369 CARROLL PARK DR., SUITE A SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JAMAL D RUSHY Other 510(k) Applications for this Contact
Regulation Number	888.3720   More FDA Info for this Regulation Number
Classification Product Code	KWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1998
Decision Date	06/30/1998
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