Skip to content

7241

by Stryker Leibinger

Ref 7241

7241 is a Class I device made by Stryker Leibinger, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-07613252083696), cleared under FDA 510(k) K981374 on 2 Jul 1998 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07613252083696), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K981374

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07613252083696 Basic UDI-DI 07613252083696UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252083696 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK981374 Date2 Jul 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07613252083696 registered 5 Nov 2026 Active
  • FDA 510(k) K981374 decided 2 Jul 1998 Active
  • FDA GUDID UDI-DI 07613252083696 listed 24 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K981374
  2. Listed FDA GUDID 07613252083696
  3. Registered EUDAMED B-07613252083696

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Intranasal splint, non-biodegradable
Model / Ref / Catalog
7241
Primary DI / UDI-DI
07613252083696
Basic UDI-DI
B-07613252083696
510(k) Number
FDA product code
LYA
EMDN code
P900403 Non-resorbable filling and reconstruction devices
GMDN term
Intranasal splint, non-biodegradable
Device class
Class I
Regulation number
874.4780
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 26.0 Millimeter
Width — 19.0 Millimeter

Similar devices in this category

Other devices filed under NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Stryker Leibinger

  • 92-55772

    Class II
  • 92-55773

    Class II
  • 92-55771

    Class II
  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)