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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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317 records meeting your search criteria returned- Product Code: KWP Product Problem: Fracture Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ZIMMER BIOMET SPINE INC. 3.5MM X 16MM CC TRANSLATING SCREW 07/07/2020
STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT 06/23/2020
STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT 06/23/2020
MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON LEGACY SPINAL SYSTEM 04/11/2020
ORTHOPEDIATRICS, INC RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLY 03/20/2020
ORTHOPEDIATRICS, INC RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLY 03/04/2020
ORTHOPEDIATRICS, INC RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLY 03/04/2020
ORTHOPEDIATRICS, CORP 5.0 ROD, COCR, SINGLE HEX 500 MM 03/02/2020
ORTHOPEDIATRICS, CORP UNKNOWN RESPONSE 6.0 COCR ROD 02/25/2020
ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 MINI REDUCER 02/17/2020
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