Class Class II

NovaBone Putty – Synthetic Bioactive Bone Graft (K242299)

K242299 2024-09-25 Traditional
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Description

NovaBone Putty - Synthetic Bioactive Bone Graft by Novabone Products, LLC, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242299
Clearance Date2024-09-25
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045

Categories

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Predicate lineage for K242299

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. NovaBone Putty – Synthetic Bioactive Bone Graft (K242299) cites 4 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB...Novabone Products, LLC2024
K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine2022
K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ...Nu Vasive, Incorporated2021
K082672NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC2008

Later devices that cite this one as their predicate

Devices that cite K242299
K numberDeviceApplicantYear
K243474MagnetOs MISKuros Biosciences B.V2025

Trace the full predicate network for K242299

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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