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510(k) K032215

VKS/TC-PLUS REVISION KNEE by Plus Orthopedics — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2003
Date Received
July 21, 2003
Clearance Type
Special
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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  • K061362 — PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (October 6, 2006)
  • K032126 — PROMOS SHOULDER (January 8, 2004)
  • K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM (December 18, 2003)
  • K032709 — MODULAR PLUS HIP STEM (September 23, 2003)
  • K032548 — IP-XS COMPRESSION NAIL SYSTEM (September 10, 2003)
  • K032052 — UC-PLUS SOLUTION UNICONDYLAR KNEE (July 25, 2003)

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