ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

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

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Reunion Reversible Fracture System (rfx), Reunion Reverse Shoulder Arthroplasty System (rsa), Reunion Total Shoulder Arthroplasty System (tsa).

Pre-market Notification Details

Device IDK210861
510k NumberK210861
Device Name:ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactJonathan Schell
CorrespondentJonathan Schell
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-23
Decision Date2021-09-03

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