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510(k) K043410

EPIPHYSIS SCREW by I.T.S. Implantat-Technologie-Systeme GmbH — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2005
Date Received
December 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K051642 — FR.O.H. CALCANEUS REPAIR SYSTEM (August 22, 2005)
  • K052011 — PILONPLATE WITH ANGULAR STABILITY (August 10, 2005)
  • K051412 — HUMERAL HEAD PLATE WITH ANGULAR STABILITY (July 11, 2005)

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