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G-Beam Fusion Beaming System 1

by Orthofix, Inc. 12 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

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 Number18053504360827 UDI-DI Date23 Mar 2018ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
G-Beam Fusion Beaming System
Generic Name
Surgical screwdriver, reusable
Model / Ref / Catalog
1, 187336
Primary DI / UDI-DI
18053504360827
510(k) Number
FDA Product Code
HWC
GMDN Term
Surgical screwdriver, reusable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.4 Millimeter

Related devices

Category: Surgical screwdriver, reusable

Cleared under the same submission (K172698)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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