FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034589602
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5161-00-1090
Catalog number
5161001090
Device description
TRIALTIS Spine System Tap,Navigated 9.0mm 3-12cm ± 1%
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
10705034589602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503458960210705034589602

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
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07613153045847XIA IIStryker CorporationNKB2014-12-08
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07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
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07613153045960XIA IIStryker CorporationNKB2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationNKB2014-12-08
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07613153046165XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046172XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153140344XIA IIStryker CorporationNKB2014-12-08
07613153140351XIA IIStryker CorporationNKB2014-12-08