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3D Offset Imaging Set SPX1

by Ecential Robotics

Ref A00038

3D Offset Imaging Set SPX1 (A00038) is a device classified as Class I in the EU and Class II in the US made by Ecential Robotics, cleared under FDA 510(k) K220946 on 15 Apr 2022, registered in EUDAMED on 2 Dec 2021 (Basic UDI-DI B-03701311500391) and listed in FDA GUDID since 1 Mar 2023 (UDI-DI 03701311500391), active (FDA 510(k), EUDAMED), not in commercial distribution (GUDID) as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDD 510(k)

Valid until

No date given

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) K220946

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03701311500391 UDI-DI Date1 Mar 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK220946 Date15 Apr 2022IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-03701311500391 Basic UDI-DI 03701311500391UDI-DIDate2 Dec 2021RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K220946 decided 15 Apr 2022 Active
  • EUDAMED Basic UDI-DI B-03701311500391 registered 2 Dec 2021 Active
  • FDA GUDID UDI-DI 03701311500391 listed 1 Mar 2023 Listed

Timeline

3 dated events

  1. Registered EUDAMED B-03701311500391
  2. Cleared FDA 510(k) K220946
  3. Listed FDA GUDID 03701311500391

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Optical surgical tracking system spatial marker, single-use
Model / reference
A00038
Primary DI / UDI-DI
03701311500391
Basic UDI-DI
B-03701311500391
510(k) Number
FDA product code
OWB, OXO, JAA
EMDN code
Z12130485 Stereotactic orthopaedic surgery instruments - consumables
GMDN term
Optical surgical tracking system spatial marker, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
FR-MF-000003577

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from Ecential Robotics

See all devices from Ecential Robotics →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)