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Profile-ESP Bolster

ORTHO KINEMATICS, INC. · Model 3.0 · UDI-DI 00868579000261

INW Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

103

Facilities

Description

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

Recalls

Date	Firm	Reason
2003-05-30	Chattanooga Corp.	Product contains an improper bracket for the transducer.

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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.