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SALVATION 3Di SP090225

by Wright Medical Technology, Inc.

Ref SP090225Model 08858251007087TT

SALVATION 3Di SP090225 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08858251007087TT) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797053167), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251007087TT Basic UDI-DI 00889797053167UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797053167 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007087TT registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797053167 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797053167
  2. Registered EUDAMED 08858251007087TT

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  • Withdrawn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
Salvation® EUDAMED
SALVATION 3Di GUDID
Generic name
Surgical drill guide, reusable
Device name
SALVATION 3Di Plating Instrumentation - GUIDING INSTRUMENTATION - CLASS I - REUSABLE - NON STERILE
Model / Ref / Catalog
SP090225, 08858251007087TT
Primary DI / UDI-DI
00889797053167
Basic UDI-DI
08858251007087TT
Direct marketing DI
00889797053167
FDA product code
FZX
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)