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M-Brace Air

INDACO SRL · Model 574 4XL · UDI-DI 05391512280871

IPY Prescription
10
510(k) clearances
10
Adverse events
1
Recalls
189
Facilities

Description

The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. 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. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton

Recalls

DateFirmReason
2016-02-24Ossur H / FOssur 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.