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TRIALTIS Spine System

by Medos International SARL 22 variants

Ref 5161-03-2011, 5161-03-2008, 5161-03-2009, 5161-03-2030, 5560-64-6020F, 5161-03-2003, 5161-03-2028, 5161-03-2010, 5161-03-2006, 5161-03-2005, 5161-03-2007, 5560-88-5055CS, 5560-88-5540CSModel TriALTIS Reusable Probes, TriALTIS Reusable Instruments for Insertion and Extraction, TriALTIS Spine System Connector, TriALTIS Spine System Bone Screw

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002776H Basic UDI-DI Date14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034643595 UDI-DI Date17 Jul 2025ListedStatusListed 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 23 Oct 2026.

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  • Withdrawn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-screw internal spinal fixation system connector
Surgical implant/trial-implant/sizer holder, reusable
Abdominal/ENT/orthopaedic surgical probe, reusable
Orthopaedic implant driver
Surgical implant handling forceps
Spinal bone screw, non-bioabsorbable
Orthopaedic implantation sleeve, reusable
Device Name
TriALTIS Reusable Probes
TriALTIS Manual Instruments
Parallel connectors, Axial connectors, Lateral connectors
Polyaxial, Uniplanar Screws
Model / Ref / Catalog
TriALTIS Reusable Probes, 5161-03-2011, TriALTIS Reusable Instruments for Insertion and Extraction, 5161-03-2008, 5161-03-2009, 5161-03-2030, TriALTIS Spine System Connector, 5560-64-6020F, 5161-03-2003, 5161-03-2028, 5161-03-2010, 5161-03-2006, 5161-03-2005, 5161-03-2007, TriALTIS Spine System Bone Screw, 5560-88-5055CS, 5560-88-5540CS, 5161032008, 5161032007, 5161032011, 5161032010, 5161032009, 5161032006, 5161032005, 5161032003, 5560885055CS, 5560885540CS, 5161032030, 5161032028, 5560646020F
Primary DI / UDI-DI
10705034643595, 10705034643601, 10705034643564, 10705034608846, 10705034600086, 10705034643526, 10705034608822, 10705034643571, 10705034643557, 10705034643540, 10705034643588, 10705034632766, 10705034628851
Basic UDI-DI
0705034a002776H, 0705034a002605Y, 0705034a002586D, 0705034a0025669
Direct Marketing DI
10705034643595
10705034643601
10705034643564
10705034608846
10705034643526
10705034608822
10705034643571
10705034643557
10705034643540
10705034643588
510(k) Number
FDA Product Code
NKB, LXH, HWR
EMDN Code
L031199, L091001, P09070302
GMDN Term
Bone-screw internal spinal fixation system connector
Surgical implant/trial-implant/sizer holder, reusable
Abdominal/ENT/orthopaedic surgical probe, reusable
Orthopaedic implant driver
Surgical implant handling forceps
Spinal bone screw, non-bioabsorbable
Orthopaedic implantation sleeve, reusable
Device Class
Class I EUDAMEDGUDID
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.4540
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIb
GUDID
Class I
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

  • Sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Sutures
  • CMR Substance YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID

Other properties (15)

  • 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
  • Serial Number: No
  • Manufacturing Date: No