FDA 510(k) Application Details - K073228

Device Classification Name Plate, Fixation, Bone

  More FDA Info for this Device
510(K) Number K073228
Device Name Plate, Fixation, Bone
Applicant ORTHOPRO LLC
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
Other 510(k) Applications for this Company
Contact J.D. WEBB
Other 510(k) Applications for this Contact
Regulation Number 888.3030

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

  More FDA Info for this Product Code
Date Received 11/15/2007
Decision Date 02/29/2008
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