FDA 510(k) Application Details - K980788

Device Classification Name Pin, Fixation, Threaded

  More FDA Info for this Device
510(K) Number K980788
Device Name Pin, Fixation, Threaded
Applicant ALPHATEC MFG., INC.
42-160 STATE ST.
PALM DESERT, CA 92211-5148 US
Other 510(k) Applications for this Company
Contact DAN PASTRICK
Other 510(k) Applications for this Contact
Regulation Number 888.3040

  More FDA Info for this Regulation Number
Classification Product Code JDW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/02/1998
Decision Date 05/22/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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