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CREO

GLOBUS MEDICAL, INC. · Model 5119.5811 · UDI-DI 00889095118735

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1
510(k) clearances
106
Adverse events
1
Recalls
158
Facilities

Description

CREO® 5.5, 8.5 x 110mm Uniplanar Screw

Recalls

DateFirmReason
2017-08-03OrthoPediatrics CorpThe 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

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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.