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861-0319

by Ortho Development Corp.

861-0319 is a Class I device made by Ortho Development Corp., listed in FDA GUDID since 25 Jun 2025 (UDI-DI 00822409131501), 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 Number00822409131501 UDI-DI Date25 Jun 2025ListedStatusListed 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  • Withdrawn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

Generic name
Osteotomy guide, reusable
Model / reference
861-0319
Primary DI / UDI-DI
00822409131501
FDA product code
FZX
GMDN term
Osteotomy guide, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Osteotomy guide, reusable

Other devices from Ortho Development Corp.

See all devices from Ortho Development Corp. →

Properties

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