I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

Plate, Fixation, Bone

I.T.S. GmbH

The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for I.t.s. Pelvic Reconstruction System (prs Rx & Prs Phoenix).

Pre-market Notification Details

Device IDK210935
510k NumberK210935
Device Name:I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
ClassificationPlate, Fixation, Bone
Applicant I.T.S. GmbH Autal 28 Lassnitzhoehe,  AT 8301
ContactFlorian Grill
CorrespondentJennifer Hadfield
Qserve Group, US, Inc. 350 S Main Street, Suite 309 Doylestown,  PA  18901
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2022-08-31

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