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Reform Ti CT Modular MIS Pedicle Screw System

PRECISION SPINE, INC. · Model 64-MT-0401 · UDI-DI 00840019942744

OSHMNHMNIKWPNKB Prescription
10
510(k) clearances
108
Adverse events
1
Recalls
158
Facilities

Description

Modular MIS Base Tulip

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.