FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034592305
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5161-00-5061
Catalog number
5161005061
Device description
TRIALTIS Spine System Drill Sleeve 2.4mm
Published
2024-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral pedicle screw system
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231527000
K233255000
K241893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231527000TriALTIS Navigation Enabled InstrumentsMedos International Sàrl2023-09-29OLO
K233255000CROSSNAV Navigation Enabled InstrumentsDePuy Synthes2024-06-17OLO
K241893000CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL2024-09-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034592305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503459230510705034592305

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647845TRIALTIS5161-00-508051610050802026-07-04
10705034647852TRIALTIS5161-00-508351610050832026-07-04
10705034647883TRIALTIS5161-00-508151610050812026-07-04
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882433ION-C Navigation LocatorSurgentec, LLCOLO2026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSurgentec, LLCOLO2026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSurgentec, LLCOLO2026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSurgentec, LLCOLO2026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSurgentec, LLCOLO2026-07-06
00810131882556TiLink-L Navigation Drill GuideSurgentec, LLCOLO2026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSurgentec, LLCOLO2026-07-06
00810131882617TiLink-L Navigation Impact CapSurgentec, LLCOLO2026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSurgentec, LLCOLO2026-07-06
00810131883669Ion Navigation Inserter AOSurgentec, LLCOLO2026-07-06
00810131884871ION-C Navigation Reusable TraySurgentec, LLCOLO2026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySurgentec, LLCOLO2026-07-06
10705034647845TRIALTISMedos International SàrlOLO2026-07-04
10705034647852TRIALTISMedos International SàrlOLO2026-07-04
10705034647883TRIALTISMedos International SàrlOLO2026-07-04
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08