TRIALTIS Spine System 5560725133

by Medos International Sàrl

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number10705034647012 UDI-DI	Date21 May 2025Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number—	Date—	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: TRIALTIS Spine System
Generic Name: Bone-screw internal spinal fixation system connector
Model / Ref / Catalog: 5560725133

Primary DI / UDI-DI: 10705034647012
510(k) Number: K243249
FDA Product Code: NKB
GMDN Term: Bone-screw internal spinal fixation system connector

Device Class: Class II
Regulation Number: 888.3070
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: 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