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Tracer Set 1001

by Ortoma AB (Publ)

Ref 30-199

Tracer Set 1001 (30-199) is a device classified as Class I in the EU and Class II in the US made by Ortoma AB (Publ), registered in EUDAMED on 19 May 2026 (Basic UDI-DI 735013752OTSTracersSP), cleared under FDA 510(k) K232140 on 11 Mar 2024 and listed in FDA GUDID since 1 Oct 2024 (UDI-DI 17350137520521), active as of 23 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232140

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735013752OTSTracersSP Basic UDI-DI 17350137520521UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17350137520521 UDI-DI Date1 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232140 Date11 Mar 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735013752OTSTracersSP registered 19 May 2026 Active
  • FDA 510(k) K232140 decided 11 Mar 2024 Active
  • FDA GUDID UDI-DI 17350137520521 listed 1 Oct 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2615-2025 FDA Class II initiated 28 Jul 2025

    Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Timeline

4 dated events

  1. Cleared FDA 510(k) K232140
  2. Listed FDA GUDID 17350137520521
  3. Recall initiated FDA recalls Z-2615-2025
  4. Registered EUDAMED 735013752OTSTracersSP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
OTS™ Tracer-Set EUDAMED
Tracer Set GUDID
Generic name
Electromagnetic/optical surgical navigation/tracking system
Device name
OTS Tracers
Model / Ref / Catalog
30-199, 1001
Primary DI / UDI-DI
17350137520521
Basic UDI-DI
735013752OTSTracersSP
510(k) Number
FDA product code
OLO
EMDN code
Z12011401 Surgical navigation system
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30-199
GUDID
1001
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electromagnetic/optical surgical navigation device tracking system

Cleared under the same submission (K232140)

and 8 more cleared under K232140

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Ortoma AB (Publ)

  • Pointer OT 1002 Open recall

    Class II

  • Stylet and Pin 1003 Open recall

    Class II

  • Reamer Adapter OTD 1003 Open recall

    Class II

  • Inserter Adapter OTD Straight 1002 Open recall

    Class II

See all devices from Ortoma AB (Publ) →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)