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510(k) K061362

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM by Plus Orthopedics AG — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2006
Date Received
May 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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  • K032215 — VKS/TC-PLUS REVISION KNEE (August 8, 2003)
  • K032052 — UC-PLUS SOLUTION UNICONDYLAR KNEE (July 25, 2003)

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