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TRIALTIS Spine System

by Medos International SARL 85 variants

Ref 5161-00-2120Model Navigation Enabled Instruments for the Thoracic-Lumbar-Sacral Spine

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002355Z Basic UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034589329 UDI-DIDate1 Feb 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TRIALTIS Spine System EUDAMED
Trialtis GUDID
Generic Name
Bone tap, reusable
Device Name
Navigation Enabled Driver Shaft Sleeve Awl Tip Tap for the Thoracic-Lumbar-Sacral Spine
Model / Ref / Catalog
Navigation Enabled Instruments for the Thoracic-Lumbar-Sacral Spine, 5161-00-2120, 5161002120
Primary DI / UDI-DI
10705034589329
Basic UDI-DI
0705034a002355Z
Direct Marketing DI
10705034589329
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Bone tap, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No
  • Manufacturing Date: No