inforMED
QLQClass II

Manual Instruments Designed For Use With Total Disc Replacement Devices

Orthopedic · 21 CFR 888.4515

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.

MDR events4All time
Recalls0All time
Registered firms15Currently listed
510(k) clearances8All time

Recent MDR events

4 adverse event reports on file

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Event type breakdown

Injury3
Malfunction1

Most-reported manufacturers

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Globus Medical, Inc.2Aesculap Ag1Ctl Medical Corporation1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

15 firms currently registered for this product code

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510(k) clearances

8 clearances for this product code

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