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510(k) K781870

IMPLANT, H.P. CONDYLAR by Dow Corning Corp. Healthcare Industries Materials — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1979
Date Received
November 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

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)
  • K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 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)

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  • K201393 — restor3d MTP Implant (May 25, 2022)
  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)
  • K200951 — Accu-Joint Hemi Implant (December 8, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K190543 — Cannulated Hemi Implant (May 31, 2019)
  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)