Silony Medical International AG

FDA Device Registration & Listing · Leinfelden Echterdingen Baden-Wurttemberg, DE · Registration 3012764194

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012764194
FEI Number
3012764194
Entity Name
Silony Medical International AG
City/State/Country
Leinfelden Echterdingen Baden-Wurttemberg, DE
Establishment Address
Leinfelder Strasse 60, Leinfelden Echterdingen Baden-Wurttemberg 70771, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Silony Medical GmbH (Owner Number: 10054311)
Owner / Operator Contact Address
Leinfelder Strasse 60, Leinfelden-Echterdingen, DE-BW 70771, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K150053
PMA Number
N/A

All Registered Proprietary Names

VERTICALE Cement Cannula VERTICALE Cement Plunger VERTICALE Cement Delivery Adapter VERTICALE Cement Cleaning Instrument VERTICALE Alignment Cement Adapter VERTICALE Cement Delivery Countertorque Oyster ACIF ROCCIA Chisel FAVO S-TLIF Tray, surgical, instrument ROCCIA TLIF ROCCIA ALIF Trifore(TM) Cervical Plating System CERVICAL CAGE ROCCIA ACIF STALIF C STALIF X ROCCIA PLIF Tap(s) Mallet Working Tower Frames Shaver Pusher Control Gauges Forceps Scraper Handle Adapter Loading Block (Re-)Positioning Tools Drill Guide Guiding instruments Distractor Inserter Dilatator Torque Limiter Counter Torque Implant modifier Orthopedic manual surgical instrument Paddle Sizer STALIF C MIDLINE ™ VERTICALE POSTERIOR SPINAL FIXATION SYSTEM OPEN VERTICALE POSTERIOR SPINAL FIXATION SYSTEM MIS ROCCIA MultiLIF VERTICALE Navigation CERVICAL CAGE VERTICALE Probe/Trial Oyster ACIF Trial ROCCIA Probe/Trial VERTICALE CERVICAL Probe/Trial SPECIALS Trial FAVO S-TLIF Trial Drill Awl(s) PCT System VERTICALE Cervical Poly screw VERTICALE Cervical Cross Connector VERTICALE Cervical Rod VERTICALE Cervical Occipital Plate VERTICALE Cervical Farangle Screw VERTICALE Cervical Occipital Screw VERTICALE Cervical Set screw VERTICALE Cervical Connector STALIF C; STALIF C-Ti

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2023-02-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-08-01
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-02-02
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-08-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-08-01
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-12-02
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2018-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-10-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-10-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-10-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-07
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-10-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-08
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-02-15
HXL Mallet General, Plastic Surgery Class 1 878.4800 2017-03-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-03-21
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-10-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-01-29
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2018-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-01-23
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2018-11-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-06
HXB Probe Orthopedic Class 1 888.4540 2017-03-21
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-12-16
HWJ Awl Orthopedic Class 1 888.4540 2018-08-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-10-06
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-10-06
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2020-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-07-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

Edwin Lindsay Business: RAF SOLUTIONS USA, INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Silony Medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013422236 SILONY MEDICAL GMBH Leinfelden-Echterdingen Baden-Wurttemberg, DE
3013422238 Silony Spine Corporation Doral, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012764194. Last updated year: 2026. Please use registration number 3012764194 when referencing this establishment in official correspondence.
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