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510(k) K850255

DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET by Dow Corning Corp. Healthcare Industries Materials

K850255 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET". The FDA issued a decision of Substantially Equivalent on May 1, 1985. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
  • K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
  • K843995 — TF-II HIP PROSTHESIS (April 23, 1985)
  • K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
  • K840357 — SSA HIP PROSTHESIS (February 17, 1984)
  • K831479 — METAL-BACKED ACETABULAR CUP (June 15, 1983)
  • K812864 — SILASTIC VOICE PROSTHESIS (November 24, 1981)
  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K801175 — SILASTIC II MAMMARY IMPLANT (December 18, 1980)

FDA data resources