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510(k) K803031

LAURE WRIST IMPLANT by Laure Prosthetics, Inc. — Product Code KWM

K803031 is an FDA 510(k) premarket notification submitted by Laure Prosthetics, Inc. for the device "LAURE WRIST IMPLANT". The FDA issued a decision of Substantially Equivalent on June 29, 1982. The device falls under product code KWM (Prosthesis, Wrist, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1982
Date Received
November 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

Other clearances for product code KWM

  • K880156 — VOLZ TOTAL WRIST PROSTHESIS (February 17, 1988)
  • K872502 — M.W.P. WRIST PROSTHESIS (July 23, 1987)
  • K800602 — TALEISNIK TOTAL WRIST PROSTHESIS (August 27, 1980)
  • K801157 — WEBER-MAYO WRIST (August 4, 1980)
  • K790774 — LODA WRIST PROSTHESIS (August 3, 1979)

FDA data resources