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Speed Shift SE-1520-10

by Synthes

Part of a family of 6 devices: see the family page

Ref SE-1520-10Model BME SPEEDSHIFT Implant Kits

Speed Shift SE-1520-10 (SE152010) is a device classified as Class IIb in the EU and Class II in the US made by Synthes, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 7611819a00848KL) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00810633020449), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00848KL Basic UDI-DI 00810633020449UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810633020449 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7611819a00848KL registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00810633020449 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810633020449
  2. Registered EUDAMED 7611819a00848KL

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  • Withdrawn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
Speedshift EUDAMED
Speed Shift GUDID
Generic name
Orthopaedic bone staple, non-adjustable
Device name
BME SPEEDSHIFT Implant Kits
Model / Ref / Catalog
SE-1520-10, BME SPEEDSHIFT Implant Kits, SE152010
Primary DI / UDI-DI
00810633020449
Basic UDI-DI
7611819a00848KL
FDA product code
JDR
EMDN code
P09120101 Osteosynthesis staples
GMDN term
Orthopaedic bone staple, non-adjustable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 STAPLES.

Other devices from Synthes

See all devices from Synthes →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)