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Lcp 449.687

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 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 Number10886982224262 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-2389-2016 FDA Class II initiated 28 Jun 2016

    It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.

    • Terminated Z-0323-2016 FDA Class II initiated 2 Nov 2015 on shared 510(k) K063049

    It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

    • Terminated Z-0167-2016 FDA Class II initiated 6 Oct 2015

    Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

    • Terminated Z-0380-2014 FDA Class II initiated 31 Jul 2013

    Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lcp
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
449.687, 449687
Primary DI / UDI-DI
10886982224262
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
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K063049)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: 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