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Hallmark 62-0021

by Orthofix US LLC

Hallmark 62-0021 is a Class I device made by Orthofix US LLC, listed in FDA GUDID since 1 Aug 2017 (UDI-DI 18257200017522), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18257200017522 UDI-DI Date1 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hallmark
Generic name
Bone tack inserter, basic
Model / reference
62-0021
Primary DI / UDI-DI
18257200017522
FDA product code
LXH
GMDN term
Bone tack inserter, basic
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Orthofix US LLC

See all devices from Orthofix US LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)