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Confidence Spinal Cement System 283910000

by Medos International Sàrl

Ref 283910000Model CONFIDENCE Spinal Cement System - 11cc Kit

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a000966B Basic UDI-DI 10705034209623UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034209623 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

8 recalls · FDA

    • Terminated Z-1300-2018 FDA Class II initiated 15 Dec 2017

    Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.

  • 3 recalls, same reason

    • Terminated Z-2132-2013 FDA Class II initiated 17 Apr 2013
    • Terminated Z-2133-2013 FDA Class II initiated 17 Apr 2013
    • Terminated Z-2134-2013 FDA Class II initiated 17 Apr 2013

    During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

  • 4 recalls, same reason

    • Terminated Z-0960-2013 FDA Class II initiated 15 Jan 2013
    • Terminated Z-0961-2013 FDA Class II initiated 15 Jan 2013
    • Terminated Z-0963-2013 FDA Class II initiated 15 Jan 2013
    • Terminated Z-0962-2013 FDA Class II initiated 15 Jan 2013

    Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Confidence Spinal Cement System
Generic Name
Orthopaedic cement preparation/delivery kit
Device Name
CONFIDENCE Spinal Cement System - 11cc Kit
Model / Ref / Catalog
283910000, CONFIDENCE Spinal Cement System - 11cc Kit
Primary DI / UDI-DI
10705034209623
Basic UDI-DI
0705034a000966B
510(k) Number
FDA Product Code
NDN
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN Term
Orthopaedic cement preparation/delivery kit
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3027
Medical Purpose
The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE High Viscosity Spinal Cement, which is indicated for the augmentation of pathological fractures of the vertebral body in skeletally mature patients using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma). CONFIDENCE High Viscosity Spinal cement is for single-use and is not reusable.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K060300)

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No