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510(k) K070731

PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM by Plus Orthopedics AG — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2007
Date Received
March 15, 2007
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)
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