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Simplify

by NuVasive, LLC United States EUDAMEDGUDID

Ref 7620009Model Distractors, Reusable

Product code MJOEMDN L0920

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195377105547 UDI-DIDate24 Apr 2023ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0887517DSTCTR5N Basic UDI-DIDate27 Sep 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1453-2022 FDA Class II initiated 20 Jun 2022

    Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Internal spinal fixation procedure kit, reusable
Device Name
Distractors, Reusable
Model / Reference
Distractors, Reusable, 7620009
Primary DI / UDI-DI
00195377105547
Basic UDI-DI
0887517DSTCTR5N
Direct Marketing DI
00195377105547
PMA Number
FDA Product Code
MJO
EMDN Code
L0920 Orthopaedic surgery distractors, reusable
GMDN Term
Internal spinal fixation procedure kit, reusable
Device Class
Class I EUDAMED
Class III GUDID
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000007421
Authorised representative
AJW Technology Consulting GmbH DE-AR-000004999

Other devices from Nuvasive, Inc.

See all devices from Nuvasive, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Prescription Use
  • Lot / Batch Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 0ce4d9ec-10c4-43de-969d-20f913188859 61 fields · synced 22 Oct 2026
  • FDA UDI 6fc65e5d-b8fb-450a-a0f0-2180ba79ba10 35 fields · synced 29 May 2026