FDA 510(k) Application Details - K990776

Device Classification Name Screw, Fixation, Bone

  More FDA Info for this Device
510(K) Number K990776
Device Name Screw, Fixation, Bone
Applicant AAP IMPLANTATE AG
73 EAGLES NEST RD.
DUXBURY, MA 02332 US
Other 510(k) Applications for this Company
Contact ELLEN HENKE-KNUPP
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 03/09/1999
Decision Date 04/29/1999
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



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