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Spinal Instrument 99780000

by Clariance, Inc.

Part of a family of 34 devices: see the family page

Ref 99780000

Spinal Instrument 99780000 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 Sep 2026 (Basic UDI-DI 0370078069923MAFB), cleared under FDA 510(k) K120469 on 13 Aug 2012 and listed in FDA GUDID since 22 May 2018 (UDI-DI 03700780611461), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120469

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0370078069923MAFB Basic UDI-DI 03700780611461UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780611461 UDI-DI Date22 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120469 Date13 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0370078069923MAFB registered 7 Sep 2026 Active
  • FDA 510(k) K120469 decided 13 Aug 2012 Active
  • FDA GUDID UDI-DI 03700780611461 listed 22 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120469
  2. Listed FDA GUDID 03700780611461
  3. Registered EUDAMED 0370078069923MAFB

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  • Withdrawn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
Palm Handle EUDAMED
Spinal Instrument GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Spinal Instrumentation
Model / Ref / Catalog
99780000
Primary DI / UDI-DI
03700780611461
Basic UDI-DI
0370078069923MAFB
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 (K120469)

and 8 more cleared under K120469

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
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)