FDA.reportPublic FDA data

TRIALTIS

Primary DI
20705034596904
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5560-01-00X6S
Catalog number
55600100X6S
Device description
TRIALTIS Spine System Set Screw 6 Pack T27 5.5 and 6.0
Published
2024-08-16
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231479000
K233684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231479000TriALTIS Spine SystemMedos International SARL2023-09-22NKB
K233684000TriALTIS™ Spine SystemMedos International SARL2023-12-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705034596904PrimaryGS10
10705034596907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503459690420705034596904
1070503459690710705034596907

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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
6
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425481RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425498RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425504RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425511RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425528RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425535RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425542RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2026-07-28
07290117353738CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDNKB2026-07-27
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24