PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM

Neurological Stereotaxic Instrument

PLUS ORTHOPEDICS AG

The following data is part of a premarket notification filed by Plus Orthopedics Ag with the FDA for Pigalileo Total Knee Replacement (tkr) System.

Pre-market Notification Details

Device IDK061362
510k NumberK061362
Device Name:PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk,  MA  02056
ContactPamela J Weagraff
CorrespondentPamela J Weagraff
PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk,  MA  02056
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-16
Decision Date2006-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07611996063196 K061362 000
07611996063110 K061362 000
07611996063127 K061362 000
07611996063134 K061362 000
07611996063141 K061362 000
07611996063158 K061362 000
07611996063165 K061362 000
07611996063172 K061362 000
07611996063189 K061362 000
07611996063103 K061362 000

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