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Response Navigation 01-1800-6041

by Orthopediatrics Corp.

Response Navigation 01-1800-6041 is a Class II device made by Orthopediatrics Corp., cleared under FDA 510(k) K203573 on 4 Feb 2021 and listed in FDA GUDID since 9 Jan 2024 (UDI-DI 00840194462761), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K203573

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840194462761 UDI-DI Date9 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203573 Date4 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203573 decided 4 Feb 2021 Active
  • FDA GUDID UDI-DI 00840194462761 listed 9 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203573
  2. Listed FDA GUDID 00840194462761

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Response Navigation
Generic name
Surgical screwdriver, reusable
Model / Ref / Catalog
01-1800-6041
Primary DI / UDI-DI
00840194462761
510(k) Number
FDA product code
OLO
GMDN term
Surgical screwdriver, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 Surgical screwdriver, reusable.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)