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Tibiaxys 150030SND

by Newdeal Sas

Tibiaxys 150030SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K073375 on 21 Feb 2008 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780043744), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K073375

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 Number10381780043744 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073375 Date21 Feb 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073375 decided 21 Feb 2008 Active
  • FDA GUDID UDI-DI 10381780043744 listed 9 Oct 2017 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0548-2022 FDA Class II initiated 4 Jan 2022

    The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

    • Terminated Z-1697-2014 FDA Class II initiated 28 Mar 2014 on shared 510(k) K073375

    New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K073375
  2. Recall initiated FDA recalls Z-1697-2014
  3. Listed FDA GUDID 10381780043744
  4. Recall initiated FDA recalls Z-0548-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tibiaxys
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
150030SND
Primary DI / UDI-DI
10381780043744
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K073375)

and 8 more cleared under K073375

Similar devices in this category

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

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)