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Spinal Instrument 99715012

by Clariance, Inc.

Ref 99715012Model Spinal instrumentation

Spinal Instrument 99715012 is a device classified as Class I in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 0370078069954PSTJ2), cleared under FDA 510(k) K153326 on 8 Mar 2016 and listed in FDA GUDID since 22 May 2018 (UDI-DI 03700780612840), active as of 22 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153326

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 Number0370078069954PSTJ2 Basic UDI-DI 03700780612840UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780612840 UDI-DI Date22 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK153326 Date8 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0370078069954PSTJ2 registered 7 Jul 2026 Active
  • FDA 510(k) K153326 decided 8 Mar 2016 Active
  • FDA GUDID UDI-DI 03700780612840 listed 22 May 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1986-2019 FDA Class III initiated 1 Jul 2019

    Potential for the polyaxial screw to become disassembled during implant.

Timeline

4 dated events

  1. Cleared FDA 510(k) K153326
  2. Listed FDA GUDID 03700780612840
  3. Recall initiated FDA recalls Z-1986-2019
  4. Registered EUDAMED 0370078069954PSTJ2

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  • Withdrawn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
Pince Serre Tige EUDAMED
Spinal Instrument GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
99715012, Spinal instrumentation
Primary DI / UDI-DI
03700780612840
Basic UDI-DI
0370078069954PSTJ2
510(k) Number
FDA product code
NKB, MNI, MNH
EMDN code
P090799 Spinal prostheses and stabilisation systems - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3070
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K153326)

and 8 more cleared under K153326

Similar devices in this category

Other devices filed under SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)