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Arsenal Deformity Spinal Fixation System

ALPHATEC SPINE, INC. · Model 48800-040-040 · UDI-DI 00840967158181

OSH MNI KWP NKB NMH Prescription

510(k) clearances

106

Adverse events

Recalls

158

Facilities

Description

FIXED SCREW, 4.0mm X 40mm

Recalls

Date	Firm	Reason
2017-08-03	OrthoPediatrics Corp	The 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.