Skip to content

Response Navigation 01-1800-6021

by Orthopediatrics Corp.

Ref 01-1800-6021Model 01-1007-0007

Response Navigation 01-1800-6021 is a device classified as Class I in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 08411321CIRINSTCE), cleared under FDA 510(k) K241816 on 14 Mar 2025 (1 earlier submission) and listed in FDA GUDID since 24 Feb 2021 (UDI-DI 00841132181126), 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) K241816

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIRINSTCE Basic UDI-DI 00841132181126UDI-DIDate29 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241816 Date14 Mar 2025DecidedStatusActive
United StatesGUDID listing GUDID Number00841132181126 UDI-DI Date24 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIRINSTCE registered 29 May 2026 Active
  • FDA 510(k) K241816 decided 14 Mar 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841132181126 listed 24 Feb 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K203573
  2. Listed FDA GUDID 00841132181126
  3. Cleared FDA 510(k) K241816
  4. Registered EUDAMED 08411321CIRINSTCE

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  • Withdrawn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
Orthopediatrics® Instrumentation EUDAMED
Response Navigation GUDID
Generic name
Abdominal/ENT/orthopaedic surgical probe, reusable
Model / Ref / Catalog
01-1800-6021, 01-1007-0007
Primary DI / UDI-DI
00841132181126
Basic UDI-DI
08411321CIRINSTCE
510(k) Number
FDA product code
OLO
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Abdominal/ENT/orthopaedic surgical probe, reusable

Cleared under the same submission (K203573)

and 8 more cleared under K203573

Cleared under the same submission (K241816)

and 8 more cleared under K241816

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)