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510(k) K083772

COLUMBUS REVISION KNEE SYSTEM by Aesculap Implant System, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2009
Date Received
December 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
  • K123909 — AESCULAP CESPACE XP (April 15, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)

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