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Reform POCT System

PRECISION SPINE, INC. · Model 55-IN-0140 · UDI-DI 00840019926652

HTE Prescription
0
510(k) clearances
137
Adverse events (1 deaths)
3
Recalls
175
Facilities

Description

Laminar Elevator

Recalls

DateFirmReason
2013-09-24SpineFrontier, Inc.Handles and heads may not be compatible.
2013-09-24SpineFrontier, Inc.Handles and heads may not be compatible.
2013-09-24SpineFrontier, 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.