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Osteomed 320-2916-04

by Osteomed Corp.

Osteomed 320-2916-04 is a Class I device made by Osteomed Corp., listed in FDA GUDID since 15 Sep 2026 (UDI-DI 10842528130015), 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 Number10842528130015 UDI-DI Date15 Sep 2026ListedStatusListed 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  • Withdrawn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
Osteomed
Generic name
Orthopaedic fixation implant alignment tool
Model / reference
320-2916-04
Primary DI / UDI-DI
10842528130015
FDA product code
LXH
GMDN term
Orthopaedic fixation implant alignment tool
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 Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)