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510(k) K083648

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL by Efratgo, Ltd. HI Tech Bio-Surgical — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2009
Date Received
December 9, 2008
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

Other clearances by Efratgo, Ltd. HI Tech Bio-Surgical

  • K043233 — GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL (February 1, 2005)
  • K983814 — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (January 14, 1999)

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