Nikolay Nedyalkov

FDA Filings

This page includes the latest FDA filings for Nikolay Nedyalkov. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012764194
FEI Number3012764194
NameNikolay Nedyalkov
Owner & OperatorSilony Medical GmbH
Contact AddressLeinfelder Strasse 60
Leinfelden-Echterdingen DE-BW Baden-Wurttemberg 70771 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8200 NW 27th Street
Doral, FL 33122 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO S-TLIF2019-08-01
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO S-TLIF2019-08-01
Nikolay Nedyalkov [Silony Medical GmbH]
Oyster ACIF2019-08-01
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA PLIF2019-01-08
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA TLIF2018-11-28
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ALIF2018-11-28
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA TLIF2018-11-28
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ALIF2018-11-28
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Triangular Awl (Trocar)2018-08-22
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Narrow Probe (Awl)2018-08-22
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? MIS Pedicle Awl2018-08-22
Nikolay Nedyalkov [Silony Medical GmbH]
SPECIALS Awl2018-08-22
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? T25 Screwdriver Shaft2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? T25 SD Shaft bullet head2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? T20 Screwdriver 7Nm2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Set Screw Starter2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Set Screw Starter, short, AO2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Set Screw Starter, long, AO2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Screwdriver T252018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Polyaxial Screwdriver2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? MIS Pedicle Screw Driver2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
SPECIALS Set Screw Starter2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
SPECIALS Screw Driver2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
SPECIALS Quick Reduction Wrench2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Rod Bender2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? French Bender2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE Rod Rotation Wrench2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Tap 8.2 , 9.2, cannulated2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Tap 6.2, 7.2 cannulated2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Tap 10.2, cannulated2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Parallel Compressor2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Compression Pliers2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Compression Pliers, symmetrical tip2018-02-15
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Rasp2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Rasp Curved 452018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Curette Straight, Curved, Right 45, and Curved Left 452018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Curette2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Chisel2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Chisel reinforced2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Chisel Angled 25 reinforced2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Chisel2018-02-02
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE POSTERIOR SPINAL FIXATION SYSTEM2018-01-29
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE MIS2018-01-29
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE POSTERIOR SPINAL FIXATION SYSTEM2018-01-29
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE MIS2018-01-29
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF2018-01-23
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF2018-01-23
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Rocker2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? MIS Counter Torque2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE Rod Cutter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE Removal Tool2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE MIS Dilator Guide Wire2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE Guide Wire2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
T-Handle2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA TLIF Loading Block2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Shaver2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Ring Endplate Scraper2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Removal Adapter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Paddle Sizer2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA PLIF Loading Block2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA PLIF Inserter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Ring Wrench Slotted Mallet2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA MultiLIF Paddle Sizer2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Inserter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Implant Driver2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Bone Graft Pusher2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ALIF Loading Block2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Oyster ACIF Inserter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Handle2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Handle, straight2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Handle, cannulated2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Handle, Ratchet2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO Shaver2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO S-TLIF Loading Block2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO S-TLIF Bone Graft Pusher2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO Paddle Sizer2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO Inserter2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Box Endplate Scraper2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA Mallet2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Probe2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Probe, square-end + straight2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Probe, square-end + curved2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Probe, blunt2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Probe, blunt + curved2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Pedicle Feeler (double-Probe)2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? MIS Probe2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE? Iliac Probe2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
VERTICALE Phantom Rod2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
SPECIALS Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA TLIF Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA PLIF Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ALIF Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ACIF Trail2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
Oyster ACIF Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
FAVO S-TLIF Trial2017-03-21
Nikolay Nedyalkov [Silony Medical GmbH]
ROCCIA ACIF2017-03-07

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