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 IDK143374
510k NumberK143374
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 Received2014-11-25
Decision Date2015-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
93700386998952 K143374 000
93700386954897 K143374 000
93700386954873 K143374 000

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