510(k) K031941

HOFFMANN II COMPACT BALTIMORE COUPLING by Howmedica Osteonics Corp. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2003
Date Received
June 24, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type