BLUEPRINT Patient Specific Instrumentation

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

TORNIER SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Blueprint Patient Specific Instrumentation.

Pre-market Notification Details

Device IDK161789
510k NumberK161789
Device Name:BLUEPRINT Patient Specific Instrumentation
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant TORNIER SAS 161 RUE LAVOISIER Montbonnot Saint-martin,  FR 38330
ContactAymen Azaiez
CorrespondentAymen Azaiez
TORNIER SAS 161 RUE LAVOISIER Montbonnot Saint-martin,  FR 38330
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-29
Decision Date2016-12-27
Summary:summary

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