510(k) K073331

DVO EXTENDED ARTICULATION HUMERAL HEADS by Dvo Extremity Solutions, LLC — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2008
Date Received
November 27, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type