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M-Brace Air

INDACO SRL · Model 584 S · UDI-DI 05391512281069

IPY Prescription

510(k) clearances

Adverse events

Recalls

189

Facilities

Description

The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.

Recalls

Date	Firm	Reason
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound

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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.