FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034589404
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5161-00-2070
Catalog number
5161002070
Device description
TRIALTIS Spine System Tap,Navigated Awl Tip 7.0mm 3-10cm ± 1%
Published
2024-02-01
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
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231527000TriALTIS Navigation Enabled InstrumentsMedos International Sàrl2023-09-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034589404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503458940410705034589404

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
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032501GRYPHON Flex2089582089582024-05-17
10705034165448COUGAR1891555141891555142015-09-24
10886705022649RIGIDLOOP2320092320092015-09-01
10886705022656RIGIDLOOP2320112320112015-09-01
10886705022663RIGIDLOOP2320142320142015-09-01
10886705022670RIGIDLOOP2320162320162015-09-01
10886705022687RIGIDLOOP2320172320172015-09-01
10886705022694RIGIDLOOP2320182320182015-09-01
10886705022700RIGIDLOOP2320192320192015-09-01
10886705022717RIGIDLOOP2320212320212015-09-01
10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465795Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22