ExactechGPS Total Shoulder Application, Equinoxe Planning Software

Orthopedic Stereotaxic Instrument

Blue Ortho

The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactechgps Total Shoulder Application, Equinoxe Planning Software.

Pre-market Notification Details

Device IDK213546
510k NumberK213546
Device Name:ExactechGPS Total Shoulder Application, Equinoxe Planning Software
ClassificationOrthopedic Stereotaxic Instrument
Applicant Blue Ortho 22 Chemin Du Vieux Chene Meylan,  FR 38240
ContactMatthieu Coic
CorrespondentMatthieu Coic
Blue Ortho 22 Chemin Du Vieux Chene Meylan,  FR 38240
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-08
Decision Date2022-01-06

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