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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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167 records meeting your search criteria returned- Product Code: NKB Product Problem: Material Separation Report Date From: 01/1/2009

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ManufacturerBrand NameDate Report Received
STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW 07/10/2020
STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCR 06/23/2020
K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM 05/20/2020
SPINE WAVE, INC. CAPSURE SPINAL SYSTEM 03/14/2020
MEDICREA INTERNATIONAL PASS TULIP 03/03/2020
MEDICREA INTERNATIONAL PASS TULIP GENESIS 02/19/2020
MEDICREA USA CORP. PASS TULIP 02/12/2020
ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM 02/11/2020
STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 8.5X90 12/13/2019
K2M, INC. UNKNOWN_K2M_PRODUCT 11/21/2019
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