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Navigation Unit Kit GS004

by Gyder Surgical Pty Ltd

Navigation Unit Kit GS004 is a Class II device made by Gyder Surgical Pty Ltd, cleared under FDA 510(k) K243387 on 29 Jan 2025 and listed in FDA GUDID since 18 Sep 2025 (UDI-DI 09360506000111), 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) K243387

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 Number09360506000111 UDI-DI Date18 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243387 Date29 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243387 decided 29 Jan 2025 Active
  • FDA GUDID UDI-DI 09360506000111 listed 18 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243387
  2. Listed FDA GUDID 09360506000111

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Navigation Unit Kit
Generic name
Orthopaedic stereotactic surgery system
Model / reference
GS004
Primary DI / UDI-DI
09360506000111
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic stereotactic surgery system

Cleared under the same submission (K243387)

Similar devices in this category

Other devices filed under Orthopaedic stereotactic surgery system.

Other devices from Gyder Surgical Pty Ltd

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)