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Oakworks Medical

OAKWORKS, INC. · Model Spine Positioning System II · UDI-DI 00817463022544

KXH
9
510(k) clearances
0
Adverse events
2
Recalls
18
Facilities

Description

Spine Positioning System II Large Torso - TT/EM

Recalls

DateFirmReason
2017-08-10Med Tec IncRigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040
2017-08-10Med Tec IncRigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040

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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.