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Hallu-Fix 117150ND

by Newdeal Sas

Hallu-Fix 117150ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K093781 on 22 Jan 2010 (1 earlier submission) and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780043355), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780043355 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: 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· +1 more in the status table
  • FDA GUDID UDI-DI 10381780043355 listed 9 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K021626
  2. Cleared FDA 510(k) K093781
  3. Listed FDA GUDID 10381780043355

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  • Withdrawn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
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
117150ND
Primary DI / UDI-DI
10381780043355
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K021626)

and 8 more cleared under K021626

Cleared under the same submission (K093781)

and 8 more cleared under K093781

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable, non-sterile.

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)