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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
ALPHATEC SPINE, INC. INVICTUS 11/16/2023
ORTHOPEDIATRICS, CORP SET SCREW, LARGE 11/15/2023
ALPHATEC SPINE, INC. INVICTUS 11/10/2023
K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X65 MM 11/09/2023
K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X65 MM 11/09/2023
ORTHOPEDIATRICS, CORP POLYAXIAL REDUCTION PEDICLE SCREWS 11/01/2023
AFT POLYAXIAL SCREW PERLA TL 10/31/2023
K2M, INC. UNKNOWN PEDICLE SCREW / ROD 10/26/2023
K2M, INC. UNKNOWN_K2M_PRODUCT 10/26/2023
PRECISION SPINE, INC REFORM TI MODULAR 10/20/2023
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