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Sterile and Non Sterile Spinal System

by Shandong Weigao Orthopaedic Device Company Limited. 241 variants

Ref 800214550Model WGB1Z-7-01, WGB1Z-7-04

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

CE MDR

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/MDR EUDAMED Number6903095SPIWGB1Z701PPU9 Basic UDI-DI 06939488394896UDI-DIDate9 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06939488394896 UDI-DI Date7 Jul 2016ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Multi-Axial Screw
Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
Sterile and Non Sterile Spinal System
Model / Reference
WGB1Z-7-01 EUDAMED
800214550 EUDAMED
WGB1Z-7-04 EUDAMED
8214550 GUDID
Primary DI / UDI-DI
06939488394896
Basic UDI-DI
6903095SPIWGB1Z701PPU9, 6903095SPIWGB1Z704PRUU
510(k) Number
FDA Product Code
MNH, KWP, MNI
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
WGB1Z-7-01
800214550
WGB1Z-7-04
GUDID
8214550
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000019785
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Shandong Weigao Orthopaedic Device Company Limited.

See all devices from Shandong Weigao Orthopaedic Device Company Limited. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: 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