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COSY

SIGNUS Medizintechnik GmbH · Model Tap cannulated · UDI-DI 04047844111475

LYS Prescription
4
510(k) clearances
1,273
Adverse events
1
Recalls
85
Facilities

Description

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Recalls

DateFirmReason
2006-10-20Medtronic Sofamor Danek USA IncMetal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.