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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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firebird® spinal fixation systems: firebird system; firebird deformity system; firebird® nxg spinal fixation system; phoenix® minimally invasive spinal fixation system; phoenix® cdx™ minimally invasive spinal fixation system; janus® midline fixation screw; janus® fenestrated screw Orthofix Inc. k180179 08/24/2018
pico single use negative pressure wound therapy system Smith & Nephew Medical Limited k180614 04/06/2018
sterilization pouch/roll made with tyvek Sigma Medical Supplies Corporation k180672 06/06/2018
medline green ambidextrous powder-free nitrile examination gloves with colloidal oatmeal (tested for use with chemotherapy drugs) Medline Industries, Inc. k180696 04/30/2018
signature orthodontic system Signature Orthodontics k181271 06/13/2018
5cm tag applicator, 7cm tag applicator, 10 cm tag applicator, 5 cm tag applicator (10 pack), 7cm tag applicator (10 pack), 10cm tag applicator (10 pack), localizer surgical probe, localizer surgical probe (5 pack) Health Beacons, Inc. k181692 09/25/2018
t-plus Wintecare SA k181893 01/29/2019
carboclear® pedicle screw system CarboFix Orthopedics Ltd. k182377 09/27/2018
reusable blood pressure cuff, disposable blood pressure cuff Shenzhen Caremed Medical Technology Co., Ltd. k182433 12/17/2018
lc glossfill xr S&C Polymer Silicon- und Composite Spezialitaeten GmbH k182778 04/22/2019

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