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Anterior Spinal Instrument Tray

KOROS U.S.A., INC. · Model 7580-00 · UDI-DI 10840199544117

HTE Prescription

510(k) clearances

138

Adverse events (1 deaths)

Recalls

175

Facilities

Description

Anterior Spinal Instrument Tray Consists of the Following: 1 x 7331-10, 1 x 7331-20, 1 x 7331-22, 1 x 7331-30, 1 x 7331-40, 1 x 7331-50, 1 x 7331-60, 1 x 7331-70-, 1 x 7331-90, 1 x 7386-20, 1 x 7386-30, 1 x 7386-40, 1 x 7386-50, 1 x 7388-20, 1 x 7388-30, 1 x 7388-40, 1 x 7388-50, 1 x 7389-20, 1 x 7389-30, 1 x 7389-40, 1 x 7389-52, 1 x 7349-10, 1 x 7349-20, 1 x 7349-30, 1 x 7349-12, 1 x 7349-22, 1 x 7349-32, 1 x 7462-06, 1 x 7462-09, 1 x 7462-12, 1 x 7462-16 & 1 x 7462-19

Recalls

Date	Firm	Reason
2013-09-24	SpineFrontier, Inc.	Handles and heads may not be compatible.
2013-09-24	SpineFrontier, Inc.	Handles and heads may not be compatible.
2013-09-24	SpineFrontier, Inc.	Handles and heads may not be compatible.

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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.