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Erisma®-LP 13025525

by Clariance, Inc.

Ref 13025525Model Pedicle screw

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 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/MDD EUDAMED NumberB-03700780613908 Basic UDI-DI 03700780613908UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780613908 UDI-DI Date8 Apr 2016ListedStatusListed 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

1 recall · FDA

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

    Potential for the polyaxial screw to become disassembled during implant.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Vis Polyaxiale Canulée ( Ø 5,5 Mm L 25 Mm ) EUDAMED
Erisma®-LP GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
13025525, Pedicle screw
Primary DI / UDI-DI
03700780613908
Basic UDI-DI
B-03700780613908
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 market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 25 Millimeter
Outer Diameter — 5.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K153326)

Show all (12)

Other devices from Clariance, Inc.

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No