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510(k) K050028

MAESTRO CARPAL HEMIARTHROPLASTY by Biomet Manufacturing, Inc. — Product Code KWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2005
Date Received
January 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Lunate
Device Class
Class II
Regulation Number
888.3750
Review Panel
OR
Submission Type

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Other clearances for product code KWN

  • K141920 — Wrist Hemiarthroplasty System (December 23, 2014)
  • K080997 — ASCENSION PYROCARBON LUNATE (June 17, 2008)
  • K864491 — SWANSON TITANIUM CARPAL LUNATE IMPLANT (April 15, 1987)
  • K790793 — AMC R METACARPAL COMPONENT (June 22, 1979)