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Hallu-Fix Haluinstset

by Newdeal Sas

Hallu-Fix Haluinstset is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K093781 on 22 Jan 2010 (2 earlier submissions) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780064404), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780064404 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK093781 Date22 Jan 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093781 decided 22 Jan 2010 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10381780064404 listed 22 Sep 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K021626
  2. Cleared FDA 510(k) K022599
  3. Cleared FDA 510(k) K093781
  4. Listed FDA GUDID 10381780064404

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hallu-Fix
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
HALUINSTSET
Primary DI / UDI-DI
10381780064404
510(k) Number
FDA product code
HTY, HRS
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class II
Regulation number
888.3040, 888.3030
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K021626)

and 8 more cleared under K021626

Cleared under the same submission (K022599)

and 3 more cleared under K022599

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Serial number
Other properties (11, all answered No)