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OTIS metallic trial implant

by S.B.M 8 variants

Ref EVO90FAH13Model Trial implant

OTIS metallic trial implant (EVO90FAH13) is a device classified as Class IIa in the EU and Class I in the US made by S.B.M, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-03760154000918) and listed in FDA GUDID since 19 Dec 2023 (UDI-DI 03760154000918), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154000918 Basic UDI-DI 03760154000918UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154000918 UDI-DI Date19 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760154000918 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 03760154000918 listed 19 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154000918
  2. Registered EUDAMED B-03760154000918

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Otis
Generic name
Surgical depth gauge, reusable
Device name
HTO instrument
Model / Ref / Catalog
Trial implant, EVO90FAH13, metallic trial implant
Primary DI / UDI-DI
03760154000918
Basic UDI-DI
B-03760154000918
FDA product code
LXH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical depth gauge, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 13 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Trial implant
EVO90FAH13
GUDID
metallic trial implant
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Surgical depth gauge, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)