FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034641966
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5560520465S
Catalog number
5560520465S
Device description
TRIALTIS Open Hook Wide 6.5mm 5.5 and 6.0
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
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
10705034641966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503464196610705034641966

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
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
true
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
10878528000645ENVOY671-260-95D67126095D2016-06-30
10878528000652ENVOY671-258-95D67125895D2016-06-30
10878528000669ENVOY671-260-05D67126005D2016-06-30
10878528000676ENVOY671-258-05D67125805D2016-06-30
10878528000898REVIVERC044115RC0441152016-06-30
10878528000911REVIVERC044130RC0441302016-06-30
10878528000942REVIVERC056115RC0561152016-06-30
10878528000959REVIVERC056125RC0561252016-06-30
10886704074816ENVOY671-256-05D67125605D2016-06-30
10886704075066ENVOY671-256-95DB67125695DB2016-06-30
10886704075073ENVOY671-256-95D67125695D2016-06-30
10886704075080ENVOY671-256-05DB67125605DB2016-06-30
10886704075097ENVOY671-258-05DB67125805DB2016-06-30
10886704075103ENVOY671-260-05DB67126005DB2016-06-30
10886704075110ENVOY671-258-95DB67125895DB2016-06-30
10886704075127ENVOY671-260-95DB67126095DB2016-06-30
10886704079248YOGAMC24150ZMC24150Z2017-10-31
10886704079255YOGAMC24150ZBMC24150ZB2017-10-31
10886704079262YOGAMC28150ZMC28150Z2017-10-31
10886704079415YOGAMC28150ZBMC28150ZB2017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18