OISClass IIImplant

Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation

Orthopedic · 21 CFR 888.3045

To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.

MDR events2All time

Recalls1All time

Registered firms30Currently listed

510(k) clearances1All time

Recent MDR events

2 adverse event reports on file

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Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

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Synthes Monument1 Synthes Norian1

Recalls

1 recall events for this product code

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Synthes USA
TerminatedUnknown
Norian Drillable Inject
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
Z-0617-2018 · View FDA record ↗

Registered firms

30 firms currently registered for this product code

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510(k) clearances

1 clearances for this product code

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Synthes (Usa)Jul 2, 2008
K073303 · NORIAN DRILLABLE