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Profyle 59-12049S

by Stryker GmbH

Ref 59-12049SModel 08858251004364T9

Profyle 59-12049S is an implantable bone washer (EU MDR Class IIb; FDA Class II; FDA product code HRS, Plate, Fixation, Bone) made by Stryker GmbH, registered in EUDAMED on 3 Jul 2026 (Basic UDI-DI 08858251004364T9) and listed in FDA GUDID since 1 Jul 2015 (UDI-DI 07613154754991), 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 Number08858251004364T9 Basic UDI-DI 07613154754991UDI-DIDate3 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154754991 UDI-DI Date1 Jul 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004364T9 registered 3 Jul 2026 Active
  • FDA GUDID UDI-DI 07613154754991 listed 1 Jul 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154754991
  2. Registered EUDAMED 08858251004364T9

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  • Withdrawn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
Profyle™ EUDAMED
Profyle GUDID
Generic name
Implantable bone washer
Device name
Variax Screws - Washer - Titanium Alloy - Class Iib - Sterile
Model / Ref / Catalog
59-12049S, 08858251004364T9
Primary DI / UDI-DI
07613154754991
Basic UDI-DI
08858251004364T9
FDA product code
HRS
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Implantable bone washer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Implantable bone washer

Similar devices in this category

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

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)