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Salvation SB065135

by Wright Medical Technology, Inc.

Part of a family of 36 devices: see the family page

Ref SB065135Model 08897970047AMV

Salvation SB065135 is a device classified as Class IIb in the EU and Class II in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 08897970047AMV) and listed in FDA GUDID since 1 Oct 2015 (UDI-DI 00840420119650), 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 Number08897970047AMV Basic UDI-DI 00840420119650UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420119650 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08897970047AMV registered 7 Aug 2026 Active
  • FDA GUDID UDI-DI 00840420119650 listed 1 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420119650
  2. Registered EUDAMED 08897970047AMV

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  • Withdrawn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
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device name
Salvation Fusion Bolts and Beams Implants - Bolts - Titanium Alloy - Anodized - Class Iib - Non Sterile
Model / Ref / Catalog
SB065135, 08897970047AMV
Primary DI / UDI-DI
00840420119650
Basic UDI-DI
08897970047AMV
FDA product code
HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional
Size
Outer Diameter — 6.5 Millimeter
Length — 135 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)