FDA.reportPublic FDA data

CROSSNAV CONDUIT

Primary DI
10705034647470
Brand
CROSSNAV CONDUIT
Company
Medos International Sàrl
Model
3010-21-301
Catalog number
301021301
Device description
CROSSNAV CONDUIT Straight TLIF / PLIF STRAIGHT POSTERIOR OSTEOTOME 0.25in
Published
2026-07-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254157000CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL2026-05-26OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034647470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503464747010705034647470

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
false
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
true

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
10705034648200VELYS4516110644516110642026-10-09
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

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Primary DI, Brand, Company table
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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
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04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
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04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
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04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
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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
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