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510(k) K022204

VKS KNEE SYSTEM by Plus Orthopedics — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2002
Date Received
July 5, 2002
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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  • K032709 — MODULAR PLUS HIP STEM (September 23, 2003)
  • K032548 — IP-XS COMPRESSION NAIL SYSTEM (September 10, 2003)
  • K032215 — VKS/TC-PLUS REVISION KNEE (August 8, 2003)

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