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510(k) K931265

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND by Ferguson Medical — Product Code JWI

Clearance Details

Decision
SN ()
Decision Date
May 22, 1995
Date Received
March 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

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  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K972217 — ORTHOPEDIC SCREW 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)
  • K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)

Other clearances for product code JWI

  • K940297 — UNIVERSAL WRIST (February 6, 1995)
  • K792687 — ASPERGILLUS SP., ANTIGEN (January 17, 1980)