Class Class II

Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706)

K243706 2025-01-17 Traditional
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Description

Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules by Medtronic Sofamor Danek, Inc., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243706
Clearance Date2025-01-17
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045

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Predicate lineage for K243706

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. Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706) cites 6 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine2022
K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ...Nu Vasive, Incorporated2021
K141824MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIPMedtronic Sofamor Danek, Inc.2014
K082166MASTERGRAFT STRIPMedtronic Sofamor Danek2009
K082918MASTERGRAFT RESORBABLE CERAMIC GRANULESMedtronic Sofamor Danek2009
K071813MASTERGRAFT PUTTYMedtronic Sofamor Danek2007

Trace the full predicate network for K243706

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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