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510(k) K801157

WEBER-MAYO WRIST by Depuy, Inc. — Product Code KWM

K801157 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "WEBER-MAYO WRIST". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code KWM (Prosthesis, Wrist, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
May 14, 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 by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code KWM

  • K880156 — VOLZ TOTAL WRIST PROSTHESIS (February 17, 1988)
  • K872502 — M.W.P. WRIST PROSTHESIS (July 23, 1987)
  • K803031 — LAURE WRIST IMPLANT (June 29, 1982)
  • K800602 — TALEISNIK TOTAL WRIST PROSTHESIS (August 27, 1980)
  • K790774 — LODA WRIST PROSTHESIS (August 3, 1979)

FDA data resources