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510(k) K915584

CRK CONDYLAR RESURFACING TOTAL KNEE by Implantology Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
December 13, 1991
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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  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • K915527 — CPS ACETABULAR COMPONENT (June 24, 1993)
  • K915385 — PPC HIP STEM COMPONENT (May 17, 1993)
  • K915391 — FPC HIP STEM COMPONENT (April 30, 1993)
  • K924099 — UFC HIP STEM COMPONENT (April 30, 1993)
  • K915798 — PSK POSTERIOR STABILIZED TOATAL KNEE (March 4, 1993)

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