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Apex 5047-1-030

by Stryker Corp.

Ref 5047-1-030Model 08858251002798TY

Apex 5047-1-030 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 28 Jul 2026 (Basic UDI-DI 08858251002798TY), cleared under FDA 510(k) K861766 on 8 Jul 1986 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 07613327081848), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K861766

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002798TY Basic UDI-DI 07613327081848UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327081848 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK861766 Date8 Jul 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002798TY registered 28 Jul 2026 Active
  • FDA 510(k) K861766 decided 8 Jul 1986 Active
  • FDA GUDID UDI-DI 07613327081848 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K861766
  2. Listed FDA GUDID 07613327081848
  3. Registered EUDAMED 08858251002798TY

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  • Withdrawn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

Trade name
Apex® EUDAMED
Apex GUDID
Generic name
Bone nail implantable cap
Device name
Apex Instruments - End Caps - Class I - Non Sterile
Model / Ref / Catalog
5047-1-030, 08858251002798TY
Description
Disposable end caps (Brown) Apex Dia 3mm
Primary DI / UDI-DI
07613327081848
Basic UDI-DI
08858251002798TY
510(k) Number
FDA product code
JDW
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone nail implantable cap
Device class
Class I EUDAMED
Class II GUDID
Regulation number
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K861766)

and 8 more cleared under K861766

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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