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Lantern 403579

by Orthalign, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K200892; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810832032243 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK242616 Date3 Oct 2024DecidedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1630-2026 FDA Class II initiated 10 Feb 2026 on shared 510(k) K200892
    • Ongoing Z-1629-2026 FDA Class II initiated 10 Feb 2026 on shared 510(k) K200892

    Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Lantern
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
403579
Primary DI / UDI-DI
00810832032243
510(k) Number
FDA product code
ONN
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K200892)

Show all (12)

Cleared under the same submission (K242616)

Show all (12)

Other devices from Orthalign, Inc.

  • Lantern ASC 503000

    Class II

  • Lantern ASC 407001-02

    Class II

  • Lantern 405310 Open recall

    Class II

  • Lantern ASC 407001-01

    Class II

  • Lantern 402546 Open recall

    Class II

  • Lantern ASC 407000

    Class II

See all devices from Orthalign, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied 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