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Prometheus Pelvic Splint

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Model PRO400 · UDI-DI 05060483570044

510(k) clearances

Adverse events

Recalls

Facilities

Description

The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Polyester, which is colored either yellow for the standard PPS, or dark green for the tactical version of the PPS. The bottom layer is also 100% polyester but is colored black for both the standard and the tactical PPS and has a velour finish so is glossy in appearance. The PPS also features two identical 100% nylon belts (blue for the PPS, or black for the tactical version of the PPS), each with a square tab at one end and a triangular anchor at the other. The tab and anchor both feature 100% nylon hook material on the inner surface so allow adherence to the knitted polyester layer on the neoprene. The two identical 100% nylon belts are thread through a 100% nylon tri-glide buckle (black). The PPS is intended for the emergency management of suspected pelvic fracture(s).

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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.