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510(k) K103002

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

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

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  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)
  • K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (December 20, 2010)

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