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510(k) K781756

SILASTIC H.P. TRAPEXIAL IMPLANT by Dow Corning Corp. Healthcare Industries Materials — Product Code KYI

K781756 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "SILASTIC H.P. TRAPEXIAL IMPLANT". The FDA issued a decision of Substantially Equivalent on November 15, 1978. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1978
Date Received
October 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
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)

Other clearances for product code KYI

  • K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (December 2, 2020)
  • K180744 — Stablyx CMC Arthroplasty Implant System (April 11, 2018)
  • K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (December 30, 2011)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (December 15, 2009)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)

FDA data resources