FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034607580
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5560885525
Catalog number
5560885525
Device description
TRIALTIS Uniplanar Screw Solid ø5.5mm x 25mm 5.5 and 6.0
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253249000TriALTIS™ Spine SystemMedos International SARL2025-10-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034607580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503460758010705034607580

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705002085BIOKNOTLESS ORTHOCORD ETHIBOND2127222127222015-09-01
10886705002122BIOKNOTLESS ORTHOCORD ETHIBOND2127262127262015-09-01
10886705007530HEALIX PEEK ORTHOCORD2222052222052015-09-01
10886705007554HEALIX PEEK ORTHOCORD2222072222072015-09-01
10886705007578HEALIX PEEK ORTHOCORD2222092222092015-09-01
10886705007585HEALIX PEEK ORTHOCORD2222102222102015-09-01
10886705007639HEALIX PEEK ORTHOCORD2222152222152015-09-01
10886705007677HEALIX PEEK ORTHOCORD2222192222192015-09-01
10886705007691HEALIX PEEK ORTHOCORD2222212222212015-09-01
10886705007769ORTHOCORD HEALIX BR2222292222292015-09-01
10886705007783ORTHOCORD HEALIX BR2222322222322015-09-01
10886705007790ORTHOCORD HEALIX BR2222332222332015-09-01
10886705007844ORTHOCORD HEALIX BR2222382222382015-09-01
10886705007851ORTHOCORD HEALIX BR2222392222392015-09-01
10886705013616INTRAFIX2546802546802015-09-01
10886705013623INTRAFIX2546812546812015-09-01
10886705013630INTRAFIX2546822546822015-09-01
10886705013647INTRAFIX2546832546832015-09-01
10886705013654INTRAFIX2546842546842015-09-01
10886705013661INTRAFIX2546852546852015-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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