FDA.reportPublic FDA data

VELYS

Primary DI
10705034648200
Brand
VELYS
Company
Medos International Sàrl
Model
451611064
Catalog number
451611064
Device description
VELYS SPINE THORACOLUMBAR CLAMP SHORT ANGLED
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034648200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503464820010705034648200

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical tracking system spatial marker holderA component of a surgical navigation and/or tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for optical spatial markers (e.g., reflective marker spheres) that are attached to it prior to use. It can be attached to the distal end of an ultrasound transducer (US probe), neurosurgical instrument, hand-held pointer manipulated by the surgeon, or a patient reference point (e.g., head clamp), and is used as part of the tracking system to provide the correct position of the surgical devices and patient. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04
00856879006281FIBERGRAFT Aeridyan Matrix59000063590000632021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres LBrainlab SEOLO2026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
04056481147693Quip Instrument Adapter Clamp Size SBrainlab SEOLO2026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size MBrainlab SEOLO2026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size LBrainlab SEOLO2026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular InstrumentsBrainlab SEOLO2026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
04250337121626joimax® Intracs® EM Patient Tracker 3DJoimax GmbHOLO2026-10-29
04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26