510(k) K042899

SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS by Synthes (Usa) — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
October 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type