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Va-Lcp 03.231.006

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982077332 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1125-2014 FDA Class II initiated 5 Feb 2014

    Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

    • Terminated Z-0401-2014 FDA Class II initiated 29 May 2013

    A plate was inadvertently released to a sales consultant that was restricted for sale.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Va-Lcp
Generic Name
Orthopaedic implant aiming arm
Model / Ref / Catalog
03.231.006, 03231006
Primary DI / UDI-DI
10886982077332
510(k) Number
FDA Product Code
HRS, HWC, JDP
GMDN Term
Orthopaedic implant aiming arm
Device Class
Class II
Regulation Number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant aiming arm

Cleared under the same submission (K110354)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No