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690015

by Stryker GmbH

Ref 690015Model 08858251003166SU

690015 is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI 08858251003166SU), cleared under FDA 510(k) K973438 on 9 Dec 1997 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 37613327072472), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K973438

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003166SU Basic UDI-DI 37613327072472UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number37613327072472 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK973438 Date9 Dec 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251003166SU registered 11 Sep 2026 Active
  • FDA 510(k) K973438 decided 9 Dec 1997 Active
  • FDA GUDID UDI-DI 37613327072472 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K973438
  2. Listed FDA GUDID 37613327072472
  3. Registered EUDAMED 08858251003166SU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Orthopaedic bone pin, non-bioabsorbable
Device name
Pins and Wires - Pin - Titanium Alloy - Class Iib - Non Sterile
Model / Ref / Catalog
690015, 08858251003166SU
Primary DI / UDI-DI
37613327072472
Basic UDI-DI
08858251003166SU
Unit of use DI
07613327072471
510(k) Number
FDA product code
HRS, HTY
EMDN code
P09120301 Kirschner bone wires
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 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
Size
Length — 150.0 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: Orthopaedic bone pin, non-bioabsorbable

Similar devices in this category

Other devices filed under KIRSCHNER BONE WIRES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)