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TRIALTIS Spine System

by Medos International SARL 462 variants

Ref 5560-60-4130CSModel TriALTIS Spine System Rod

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253249↗

+4 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a0025567 Basic UDI-DI 10705034598420UDI-DIDate30 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK253249 Date21 Oct 2025IssuedStatusActive
United StatesGUDID listing GUDID Number10705034598420 UDI-DI Date12 Jul 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
TRIALTIS Spine System EUDAMED
Trialtis GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
TriALTIS Spine System Rod, 5560-60-4130CS, 5560604130CS
Primary DI / UDI-DI
10705034598420
Basic UDI-DI
0705034a0025567
510(k) Number
FDA Product Code
NKB
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TRIALTIS Spine System is an implantable spinal rod system designed for use in spinal fixation procedures. It includes multiple rod configurations such as lordosed rods, straight rods, and variants with hex ends, BLT Viper ends, or combinations thereof.

Supplied sterile and intended for single-use implantation, the system is manufactured by Medos International SARL and authorized under FDA 510(k) and MDR regulations. Each rod is identified by reference 5560-60-4130CS and is not reusable, not active, and does not contain animal or human tissues.

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Medos International SARL

See all devices from Medos International SARL →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the TRIALTIS Spine System sterile when supplied?

    Yes, the device is supplied sterile as indicated by the STERILE field being set to 1 in the specifications.

  • Can the TRIALTIS Spine System rods be reused after implantation?

    No, the rods are single-use only, as the REUSABLE field is 0, meaning they are not designed for reprocessing or reuse.

  • What authorization pathways apply to the TRIALTIS Spine System?

    The device is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, as listed in the AUTHORIZATIONS field.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No