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Gamma 8420-1240S

by Stryker GmbH

Part of a family of 468 devices: see the family page

Ref 8420-1240SModel 08858251003273SW

Gamma 8420-1240S is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 08858251003273SW) and listed in FDA GUDID since 28 Mar 2022 (UDI-DI 07613327478730), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003273SW Basic UDI-DI 07613327478730UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327478730 UDI-DI Date28 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003273SW registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327478730 listed 28 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327478730
  2. Registered EUDAMED 08858251003273SW

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  • Withdrawn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
Gamma
Generic name
Femur intramedullary nail
Device name
Gamma 4 Implants - Long Nail - Titanium Alloy - Class Iib - Sterile
Model / Ref / Catalog
8420-1240S, 08858251003273SW
Primary DI / UDI-DI
07613327478730
Basic UDI-DI
08858251003273SW
FDA product code
HSB
EMDN code
P09120202 Intramedullary nails in complex systems
GMDN term
Femur intramedullary nail
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 240.0 Millimeter

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: Femur intramedullary nail

Similar devices in this category

Other devices filed under BONE FIXATION NAILS.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)