BonOs® Inject Bone Cement; NEO Pedicle Screw System™

Bone Cement, Posterior Screw Augmentation

Neo Medical SA

The following data is part of a premarket notification filed by Neo Medical Sa with the FDA for Bonos® Inject Bone Cement; Neo Pedicle Screw System™.

Pre-market Notification Details

Device IDK222256
510k NumberK222256
Device Name:BonOs® Inject Bone Cement; NEO Pedicle Screw System™
ClassificationBone Cement, Posterior Screw Augmentation
Applicant Neo Medical SA Route De Lausanne 157 A Villette (Lavaux),  CH 1096
ContactJonas Larsson
CorrespondentSandra Soniec
meditec Consulting GmbH Obermoosstrasse 23 Boll,  CH 3067
Product CodePML  
Subsequent Product CodeNDN
Subsequent Product CodeNKB
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-27
Decision Date2022-08-26

Trademark Results [BonOs]

Mark Image

Registration | Serial
Application Date
79030690 3392067 Live/Registered
Osartis GmbH

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