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Oscar 3 1

by Orthofix SRL 19 variants

Part of a family of 19 devices: see the family page

Ref EXP2681SUModel ULTRASOUND SURGERY INSTRUMENTS - HARDWARE

Oscar 3 1 (EXP2681SU) is a device classified as Class IIa in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436UsInstrum2a23A2T), cleared under FDA 510(k) K093805 on 19 Feb 2010 and listed in FDA GUDID since 18 Sep 2017 (UDI-DI 18056099649834), active as of 12 Nov 2026.

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

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093805

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436UsInstrum2a23A2T Basic UDI-DI 18056099649834UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18056099649834 UDI-DI Date18 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093805 Date19 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436UsInstrum2a23A2T registered 22 Oct 2026 Active
  • FDA 510(k) K093805 decided 19 Feb 2010 Active
  • FDA GUDID UDI-DI 18056099649834 listed 18 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093805
  2. Listed FDA GUDID 18056099649834
  3. Registered EUDAMED 805050436UsInstrum2a23A2T

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  • Withdrawn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
Oscar EUDAMED
Oscar 3 GUDID
Generic name
Hard/soft-tissue ultrasonic surgical system
Model / Ref / Catalog
ULTRASOUND SURGERY INSTRUMENTS - HARDWARE, EXP2681SU, 1
Primary DI / UDI-DI
18056099649834
Basic UDI-DI
805050436UsInstrum2a23A2T
510(k) Number
FDA product code
LZV, JDX
EMDN code
Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term
Hard/soft-tissue ultrasonic surgical system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.4580
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ULTRASOUND SURGERY INSTRUMENTS - HARDWARE
EXP2681SU
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Hard/soft-tissue ultrasonic surgical system

Cleared under the same submission (K093805)

and 8 more cleared under K093805

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

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