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510(k) K915798

PSK POSTERIOR STABILIZED TOATAL KNEE by Implantology Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1993
Date Received
December 24, 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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  • K915385 — PPC HIP STEM COMPONENT (May 17, 1993)
  • K915391 — FPC HIP STEM COMPONENT (April 30, 1993)
  • K924099 — UFC HIP STEM COMPONENT (April 30, 1993)
  • K915584 — CRK CONDYLAR RESURFACING TOTAL KNEE (February 12, 1993)

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