FDA 510(k) Application Details - K130550

Device Classification Name

  More FDA Info for this Device
510(K) Number K130550
Device Name RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
Applicant ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
Other 510(k) Applications for this Company
Contact WILLIAM GARZON
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 03/04/2013
Decision Date 03/24/2014
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