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510(k) K761020

ANKLE (FREEMAN-SWANSON) by Medishield, Inc. — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1976
Date Received
November 11, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

Other clearances by Medishield, Inc.

  • K781103 — SPECTRASCAN (September 27, 1978)
  • K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE (May 3, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON. (January 26, 1977)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 1976)
  • K760668 — SELECTATEC SYSTEM (September 27, 1976)

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