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Salvation SP082560

by Wright Medical Technology, Inc.

Ref SP082560Model 08858251007090TG

Salvation SP082560 is a device classified as Class IIa in the EU and Class I in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08858251007090TG) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797060684), 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 Number08858251007090TG Basic UDI-DI 00889797060684UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797060684 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007090TG registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797060684 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797060684
  2. Registered EUDAMED 08858251007090TG

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  • Withdrawn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 GUDID
Generic name
Fluted surgical drill bit, reusable
Device name
SALVATION 3Di Plating Instrumentation- DRILLING INSTRUMENTATION - CLASS IIa - NON STERILE
Model / Ref / Catalog
SP082560, 08858251007090TG
Primary DI / UDI-DI
00889797060684
Basic UDI-DI
08858251007090TG
Direct marketing DI
00889797060684
FDA product code
GFG
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)