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 IDK212489
510k NumberK212489
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-10-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640177820846 K212489 000
07640177820525 K212489 000
07640177820532 K212489 000
07640177820549 K212489 000
07640177820556 K212489 000
07640177820563 K212489 000
07640177820686 K212489 000
07640177820693 K212489 000
07640177820709 K212489 000
07640177820716 K212489 000
07640177820723 K212489 000
07640177820730 K212489 000
07640177820747 K212489 000
07640177820754 K212489 000
07640177820761 K212489 000
07640177820518 K212489 000

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