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510(k) K080997

ASCENSION PYROCARBON LUNATE by Ascension Orthopedics, Inc. — Product Code KWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2008
Date Received
April 8, 2008
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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  • K162153 — Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (July 14, 2017)
  • K160830 — Integra External Fixation System (July 6, 2016)
  • K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (December 23, 2015)
  • K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System (October 29, 2015)
  • K151459 — Integra Total Ankle Replacement System (August 31, 2015)
  • K142413 — TITAN Modular Total Shoulder System (November 14, 2014)
  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)

Other clearances for product code KWN

  • K141920 — Wrist Hemiarthroplasty System (December 23, 2014)
  • K050028 — MAESTRO CARPAL HEMIARTHROPLASTY (March 25, 2005)
  • K864491 — SWANSON TITANIUM CARPAL LUNATE IMPLANT (April 15, 1987)
  • K790793 — AMC R METACARPAL COMPONENT (June 22, 1979)