FDA.reportPublic FDA data

TRIALTIS Spine System

Primary DI
10705034585321
Brand
TRIALTIS Spine System
Company
DEPUY SPINE, LLC
Model
5560-12-4560FS
Catalog number
5560124560FS
Device description
TRIALTIS Spine System Polyaxial Screw Fenestrated ø4.5mm x 60mm 5.5 and 6.0
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
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
10705034585321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503458532110705034585321

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.

Contacts#

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

Regulatory Flags#

DUNS number
107105876
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034245973CONDUIT2761-01-0152761010152015-09-24
10705034245980CONDUIT2761-01-0102761010102015-09-24
10705034245997CONDUIT2761-01-0052761010052015-09-24
10705034245966CONDUIT2761-01-0302761010302015-09-24
10705034604572CROSSNAV3020-20-0012025-02-14
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122997ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123000ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123017ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123024ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123031ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123048ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123055ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123062ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123079ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123086ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123093ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123109ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123116ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123123ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123130ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123147ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123154ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123161ZAVATION SCREWZavation LLCNKB2026-10-20