Skip to content

OTIS Hammer

by S.B.M

Ref EVO90FAMARModel Hammer

OTIS Hammer (EVO90FAMAR) is a Class I device made by S.B.M, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 376015400DT2018033VB) and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 03760154006262), active as of 24 Oct 2026.

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

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376015400DT2018033VB Basic UDI-DI 03760154006262UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154006262 UDI-DI Date20 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376015400DT2018033VB registered 16 Jul 2026 Active
  • FDA GUDID UDI-DI 03760154006262 listed 20 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154006262
  2. Registered EUDAMED 376015400DT2018033VB

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Otis® EUDAMED
Otis GUDID
Generic name
Surgical mallet
Device name
Hammer for HTO
Model / Ref / Catalog
Hammer, EVO90FAMAR
Primary DI / UDI-DI
03760154006262
Basic UDI-DI
376015400DT2018033VB
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical mallet
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS 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 (19, all answered No)