FDA 510(k) Application Details - K190035

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K190035
Device Name	Screw, Fixation, Bone
Applicant	Biomet Inc 56 East Bell Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Andrew Steward Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2019
Decision Date	02/07/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review