FDA 510(k) Application Details - K943806

Device Classification Name Screw, Fixation, Bone

  More FDA Info for this Device
510(K) Number K943806
Device Name Screw, Fixation, Bone
Applicant BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN US
Other 510(k) Applications for this Company
Contact MARY L VERSTYNEN
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 08/04/1994
Decision Date 07/03/1995
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact