Class Class II

Cove Putty, OsteoCove Putty (K242273)

K242273 2024-09-25 Traditional
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Description

Cove Putty, OsteoCove Putty by SeaSpine Orthopedics Corporation, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242273
Clearance Date2024-09-25
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045

Categories

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Predicate lineage for K242273

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. Cove Putty, OsteoCove Putty (K242273) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC2023
K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation2023
K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ...Nu Vasive, Incorporated2021

Trace the full predicate network for K242273

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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