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Advansys Mlp 181052SND

by Newdeal Sas

Advansys Mlp 181052SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K070241 on 8 Feb 2007 (1 earlier submission) and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780044055), 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

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780044055 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK070241 Date8 Feb 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070241 decided 8 Feb 2007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780044055 listed 9 Oct 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-2123-2012 FDA Class II initiated 9 Feb 2012

    Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.

Timeline

4 dated events

  1. Cleared FDA 510(k) K060476
  2. Cleared FDA 510(k) K070241
  3. Recall initiated FDA recalls Z-2123-2012
  4. Listed FDA GUDID 10381780044055

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Advansys Mlp
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
181052SND
Primary DI / UDI-DI
10381780044055
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 (K060476)

and 8 more cleared under K060476

Cleared under the same submission (K070241)

and 8 more cleared under K070241

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)