510(k) K103002

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM by Synthes (Usa) — Product Code HSB

K103002 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 2011. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2011
Date Received
October 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type