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Erisma®-LP 13028580

by Clariance, Inc.

Ref 13028580Model Pedicle screw

Erisma®-LP 13028580 is a device classified as Class IIb in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-03700780614806), cleared under FDA 510(k) K153326 on 8 Mar 2016 and listed in FDA GUDID since 8 Apr 2016 (UDI-DI 03700780614806), 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 MDD 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/MDD EUDAMED NumberB-03700780614806 Basic UDI-DI 03700780614806UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780614806 UDI-DI Date8 Apr 2016ListedStatusListed 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 B-03700780614806 registered 30 Jun 2026 Active
  • FDA 510(k) K153326 decided 8 Mar 2016 Active
  • FDA GUDID UDI-DI 03700780614806 listed 8 Apr 2016 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 03700780614806
  3. Recall initiated FDA recalls Z-1986-2019
  4. Registered EUDAMED B-03700780614806

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  • Withdrawn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
Vis Polyaxiale Canulée ( Ø 8,5 Mm L 80 Mm ) EUDAMED
Erisma®-LP GUDID
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
13028580, Pedicle screw
Primary DI / UDI-DI
03700780614806
Basic UDI-DI
B-03700780614806
510(k) Number
FDA product code
NKB, MNI, MNH
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3070
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 80 Millimeter
Outer Diameter — 8.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K153326)

and 8 more cleared under K153326

Similar devices in this category

Other devices filed under THORACOLUMBOSACRAL FIXATION SYSTEMS.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)