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Sterile and Non Sterile Spinal System

by Shandong Weigao Orthopaedic Device Company Limited. 241 variants

Part of a family of 2,239+ devices: see the family page

Ref 800225540Model WGB1Z-7-04

Sterile and Non Sterile Spinal System (800225540) is a device classified as Class IIb in the EU and Class II in the US made by Shandong Weigao Orthopaedic Device Company Limited., registered in EUDAMED on 3 Mar 2026 (Basic UDI-DI 6903095SPIWGB1Z704PRUU), cleared under FDA 510(k) K160320 on 1 Apr 2016 and listed in FDA GUDID since 7 Jul 2016 (UDI-DI 06939488331068), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160320

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6903095SPIWGB1Z704PRUU Basic UDI-DI 06939488331068UDI-DIDate3 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06939488331068 UDI-DI Date7 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160320 Date1 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6903095SPIWGB1Z704PRUU registered 3 Mar 2026 Active
  • FDA 510(k) K160320 decided 1 Apr 2016 Active
  • FDA GUDID UDI-DI 06939488331068 listed 7 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160320
  2. Listed FDA GUDID 06939488331068
  3. Registered EUDAMED 6903095SPIWGB1Z704PRUU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Multi-Axial Reduction Screw
Generic name
Spinal bone screw, non-bioabsorbable
Device name
Sterile and Non Sterile Spinal System
Model / reference
WGB1Z-7-04 EUDAMED
800225540 EUDAMED
8225540 GUDID
Primary DI / UDI-DI
06939488331068
Basic UDI-DI
6903095SPIWGB1Z704PRUU
510(k) Number
FDA product code
MNI, KWP, MNH
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
WGB1Z-7-04
800225540
GUDID
8225540
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

Similar devices in this category

Other devices filed under THORACOLUMBOSACRAL FIXATION SYSTEMS.

Other devices from Shandong Weigao Orthopaedic Device Company Limited.

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

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)