SILONY MEDICAL GMBH

FDA Device Registration & Listing · Leinfelden-Echterdingen Baden-Wurttemberg, DE · Registration 3013422236

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
3013422236
FEI Number
3013422236
Entity Name
SILONY MEDICAL GMBH
City/State/Country
Leinfelden-Echterdingen Baden-Wurttemberg, DE
Establishment Address
Leinfelder Strasse 60, Leinfelden-Echterdingen Baden-Wurttemberg 70771, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical 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
N/A
PMA Number
N/A

All Registered Proprietary Names

MIDLINE II TI VERTICALE Set Screw Starter VERTICALE Screw Driver SPECIALS Set Screw Starter SPECIALS Screw Driver VERTICALE CERVICAL Screw Driver VERTICALE Navigation VERTICALE Navigation PCT System ROCCIA PLIF FAVO S-TLIF ROCCIA ACIF STALIF C VERTICALE Probe/Trial Oyster ACIF Trial ROCCIA Probe/Trial VERTICALE CERVICAL Probe/Trial SPECIALS Trial FAVO S-TLIF Trial STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti STALIF TT Tap(s) CERVICAL CAGE Oyster ACIF ROCCIA TLIF ROCCIA ALIF MIDLINE ™ ROCCIA MultiLIF ROCCIA Chisel VERTICALE GPS Instruments CERVICAL CAGE STALIF C TI, STALIF C STALIF X STALIF C Mallet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
HXX Screwdriver Orthopedic Class 1 888.4540 2018-02-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-11
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-08
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
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
HXB Probe Orthopedic Class 1 888.4540 2017-03-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-02-15
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 2019-08-01
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
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
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-02-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-06
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
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-10-06
HXL Mallet General, Plastic Surgery Class 1 878.4800 2017-03-21

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
3013422238 Silony Spine Corporation Doral, FL, US
3012764194 Silony Medical International AG Leinfelden Echterdingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K161478 Xenco Medical, LLC Xenco Medical Posterior Cervical System 2016-09-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013422236. Last updated year: 2026. Please use registration number 3013422236 when referencing this establishment in official correspondence.
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