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Smart Toe ST0A-15P

by Stryker Corp.

Ref ST0A15P

Smart Toe ST0A-15P is a device classified as Class IIb in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-07613252263395) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252263395), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07613252263395 Basic UDI-DI 07613252263395UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252263395 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07613252263395 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 07613252263395 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252263395
  2. Registered EUDAMED B-07613252263395

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  • Withdrawn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
Smart Toe
Generic name
Orthopaedic bone staple, non-adjustable
Model / Ref / Catalog
ST0A15P EUDAMED
ST0A-15P GUDID
Primary DI / UDI-DI
07613252263395
Basic UDI-DI
B-07613252263395
FDA product code
HTY
EMDN code
P091299 Osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Orthopaedic bone staple, non-adjustable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ST0A15P
GUDID
ST0A-15P
Device classEUDAMED
Class IIb
GUDID
Class II

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 staple, non-adjustable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)