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Lantern ASC 503000

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

None found

in data synced 23 Oct 2026

Documents

510(k) K253507

FDA submission, from GUDID

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 Number00810832032601 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253507 Date2 Jun 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lantern ASC
Generic name
Orthopaedic stereotactic surgery system
Model / Ref / Catalog
503000
Primary DI / UDI-DI
00810832032601
510(k) Number
FDA product code
ONN
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253507)

Other devices from Orthalign, Inc.

  • 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

  • Lantern 403579 Open recall

    Class II

See all devices from Orthalign, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No