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Response Navigation 01-1800-6038

by Orthopediatrics Corp.

Part of a family of 102 devices: see the family page

Ref 01-1800-6038Model 01-1007-0036

Response Navigation 01-1800-6038 is a device classified as Class IIa in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 08411321CIIADRV62), cleared under FDA 510(k) K203573 on 4 Feb 2021 and listed in FDA GUDID since 24 Feb 2021 (UDI-DI 00841132181171), 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) K203573

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 Number08411321CIIADRV62 Basic UDI-DI 00841132181171UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132181171 UDI-DI Date24 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203573 Date4 Feb 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIADRV62 registered 29 May 2026 Active
  • FDA 510(k) K203573 decided 4 Feb 2021 Active
  • FDA GUDID UDI-DI 00841132181171 listed 24 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203573
  2. Listed FDA GUDID 00841132181171
  3. Registered EUDAMED 08411321CIIADRV62

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  • Withdrawn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
Surgical screwdriver, reusable
Model / Ref / Catalog
01-1800-6038, 01-1007-0036
Primary DI / UDI-DI
00841132181171
Basic UDI-DI
08411321CIIADRV62
510(k) Number
FDA product code
OLO
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Surgical screwdriver, reusable

Cleared under the same submission (K203573)

and 8 more cleared under K203573

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)