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Uniplate 189707012

by Depuy Spine, Inc.

Ref 189707012

Uniplate 189707012 is a device classified as Class IIb in the EU and Class II in the US made by Depuy Spine, Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-USMF000045207000089TK), cleared under FDA 510(k) K171439 on 20 Jul 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D-USMF000045207000089TK), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171439

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000045207000089TK Basic UDI-DI D-USMF000045207000089TKUDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171439 Date20 Jul 2017DecidedStatusActive
United StatesGUDID listing GUDID NumberD-USMF000045207000089TK UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000045207000089TK registered 3 Nov 2026 Active
  • FDA 510(k) K171439 decided 20 Jul 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI D-USMF000045207000089TK listed 24 Sep 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K042544
  2. Listed FDA GUDID D-USMF000045207000089TK
  3. Cleared FDA 510(k) K171439
  4. Registered EUDAMED B-USMF000045207000089TK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Uniplate
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
189707012
Primary DI / UDI-DI
D-USMF000045207000089TK EUDAMED
10705034180779 GUDID
Basic UDI-DI
B-USMF000045207000089TK
510(k) Number
FDA product code
KWQ
EMDN code
P09070301 Cervical fixation systems
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3060
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000045207000089TK
GUDID
10705034180779
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000045207000089TK; FDA GUDID lists 10705034180779), so their flags are not compared. 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.

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K042544)

and 8 more cleared under K042544

Cleared under the same submission (K171439)

and 8 more cleared under K171439

Similar devices in this category

Other devices filed under CERVICAL FIXATION SYSTEMS.

Other devices from Depuy Spine, Inc.

See all devices from Depuy Spine, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)