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510(k) K141920

Wrist Hemiarthroplasty System by Arthrosurface, Inc. — Product Code KWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2014
Date Received
July 16, 2014
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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  • K170350 — ToeMATE® Hammertoe Correction System (March 3, 2017)
  • K162391 — AlignMATE™ Lapidus Arthrodesis System (February 21, 2017)
  • K161539 — Arthrosurface Bone Screws (June 30, 2016)

Other clearances for product code KWN

  • K080997 — ASCENSION PYROCARBON LUNATE (June 17, 2008)
  • K050028 — MAESTRO CARPAL HEMIARTHROPLASTY (March 25, 2005)
  • K864491 — SWANSON TITANIUM CARPAL LUNATE IMPLANT (April 15, 1987)
  • K790793 — AMC R METACARPAL COMPONENT (June 22, 1979)