Silony Spine Corporation

FDA Device Registration & Listing · Doral, FL, US · Registration 3013422238

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
3013422238
FEI Number
3013422238
Entity Name
Silony Spine Corporation
City/State/Country
Doral, FL, US
Establishment Address
8200 NW 27th Street, Suite #104, Doral, FL 33122, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
K254148
PMA Number
N/A

All Registered Proprietary Names

MIDLINE ™ STALIF C STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti STALIF TT CERVICAL CAGE 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 TT STALIF(TM) C STALIF MIDLINE STALIF X STALIF C TI, STALIF C STALIF C MIDLINE II TI STALIF C; STALIF C-Ti STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM VERTICALE GPS Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-06
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-03-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-10-06
OVE Intervertebral Fusion Device With Integrated Fixation, 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
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-10-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3012764194 Silony Medical International AG Leinfelden Echterdingen Baden-Wurttemberg, DE

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-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3036496433 SPECTRUM SPINE INC Jasper, GA, US
3027726367 HAPPE SPINE Grand Rapids, MI, US
3027201862 XCIX DESIGN, LLC Richmond, UT, US
3017936978 CARLSMED, INC. Carlsbad, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013422238. Last updated year: 2026. Please use registration number 3013422238 when referencing this establishment in official correspondence.
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