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510(k) K970258

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES by Ferguson Medical — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1997
Date Received
January 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Ferguson Medical

  • K033153 — DICOM THEATER (April 23, 2004)
  • K962615 — TUMORLOCALIZER MRI (March 19, 1998)
  • K963794 — PUNCTURENEEDLE (March 19, 1998)
  • K971813 — EMBLA (January 16, 1998)
  • K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K970819 — TARGOBEAM (July 14, 1997)
  • K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)
  • K960421 — SINUSCAN 102/SINUSPRINT (April 16, 1997)

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