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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
MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA¿ FENESTRATED SCREW SP 04/16/2024
NUVASIVE INC NUVASIVE RELINE SYSTEM 04/11/2024
XTANT MEDICAL HOLDINGS, INC. STREAMLINE MIS SPINAL FIXATION SYSTEM 04/11/2024
K2M, INC. SET SCREW; ATR 04/10/2024
DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T 04/09/2024
MEDOS INTERNATIONAL SàRL CH EXP PEEK SI SET SCREW 5.5 04/09/2024
NUVASIVE INC. NUVASIVE RELINE SYSTEM 04/09/2024
NUVASIVE INC. NUVASIVE RELINE SYSTEM 04/09/2024
STRYKER SPINE-US RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX 04/05/2024
STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.0 X 04/05/2024
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