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G-Beam Fusion Beaming System 1

by Orthofix, Inc. 62 variants

Ref 99-875170

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18053504360704 Basic UDI-DI 18053504360704UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18053504360704 UDI-DI Date23 Mar 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
G-Beam Fusion Beaming System
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
99-875170, 1
Primary DI / UDI-DI
18053504360704
Basic UDI-DI
B-18053504360704
510(k) Number
FDA Product Code
HWC
EMDN Code
P09120603 Cannulated screws
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5.4 Millimeter
Length — 170 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
99-875170
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K172698)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No