Skip to content

UPASS Rod

by Shandong Weigao Orthopaedic Device Company Limited. 3 variants

Part of a family of 12 devices: see the family pagePart of a family of 2,239+ devices: see the family pagePart of a family of 20 devices: see the family page

Ref 800005035, 800005070, 800005150, 800005130, 800005100, 800005030, 800005040, 800005120, 800005500, 800005075, 800005080, 800005110, 800005105Model WGB1Z-2, WGB1Z-7-23, WGB1Z-7-04

UPASS Rod (800005035) 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 10 Nov 2025 (Basic UDI-DI 6903095SPIWGB1Z2RD5S), cleared under FDA 510(k) K160320 on 1 Apr 2016 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 06939488337695), active as of 25 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 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6903095SPIWGB1Z2RD5S Basic UDI-DI Date10 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06939488337695 UDI-DI Date15 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 6903095SPIWGB1Z2RD5S registered 10 Nov 2025 Active
  • FDA 510(k) K160320 decided 1 Apr 2016 Active
  • FDA GUDID UDI-DI 06939488337695 listed 15 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160320
  2. Listed FDA GUDID 06939488337695
  3. Registered EUDAMED 6903095SPIWGB1Z2RD5S

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  • Withdrawn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
UPASS Rod EUDAMED
Connection Rod GUDID
Generic name
Bone-screw internal spinal fixation system rod
Device name
Sterile and Non Sterile Spinal System
Model / reference
WGB1Z-2 EUDAMED
800005035 EUDAMED
800005070 EUDAMED
800005150 EUDAMED
WGB1Z-7-23 EUDAMED
800005130 EUDAMED
800005100 EUDAMED
800005030 EUDAMED
800005040 EUDAMED
800005120 EUDAMED
800005500 EUDAMED
800005075 EUDAMED
800005080 EUDAMED
800005110 EUDAMED
800005105 EUDAMED
WGB1Z-7-04 EUDAMED
8005110 GUDID
8005100 GUDID
Primary DI / UDI-DI
06939488337695, 06939488337763, 06939488399129, 06912547434566, 06939488337824, 06939488337688, 06939488337701, 06939488399099, 06939488337862, 06939488337770, 06939488337787, 06912547138204, 06912547138181, 06939488337848, 06939488337831, 06939488399105
Basic UDI-DI
6903095SPIWGB1Z2RD5S, 6903095SPIWGB1Z723RDUF, 6903095SPIWGB1Z704PRUU
510(k) Number
FDA product code
MNH, KWP, MNI
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3070, 888.3050
EU registration type
Standard device
EU market of registration
Lithuania
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-2
800005035
800005070
800005150
WGB1Z-7-23
800005130
800005100
800005030
800005040
800005120
800005500
800005075
800005080
800005110
800005105
WGB1Z-7-04
GUDID
8005110
8005100
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)