AutoStrut G2

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

OrthoSpin Ltd

The following data is part of a premarket notification filed by Orthospin Ltd with the FDA for Autostrut G2.

Pre-market Notification Details

Device IDK202810
510k NumberK202810
Device Name:AutoStrut G2
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant OrthoSpin Ltd 13 Hayezira St. Yokneam,  IL 2066720
ContactOren Cohen
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-23
Decision Date2021-01-06

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