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Pulse

by NuVasive, LLC United States EUDAMEDGUDID

Ref 5050401Model Arrays, Single-Use

Product code HAWEMDN Z12011485

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0887517ARRAY2P Basic UDI-DIDate1 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00195377051004 UDI-DIDate6 May 2022ListedStatusIn distribution

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

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000315034 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    10 Jun 2026
    Expires
    14 May 2029
    Reason
    Add device or group

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1052-2023 FDA Class III initiated 19 Jul 2022

    Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Spinal rod bending system
Device Name
Arrays, Single-Use
Non-Invasive Sterile Devices
Model / Reference
Arrays, Single-Use, 5050401
Primary DI / UDI-DI
00195377051004
Basic UDI-DI
0887517ARRAY2P, 0193982SNONINVINSTJW
Direct Marketing DI
00195377051004
510(k) Number
FDA Product Code
HAW, OWB, OLO, JAA, GWF, ETN, PDQ, LLZ, IKN
EMDN Code
Z12011485 Surgical navigation instruments - consumables
GMDN Term
Spinal rod bending system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560, 892.1650, 882.1870, 874.1820, 892.2050, 890.1375
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

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
  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
Other properties (20)
  • Single Use: No
  • Implantable: 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 18aa8e31-be66-4c68-82be-d67789be0f7a 61 fields · synced 22 Oct 2026
  • FDA UDI 6c8a83a7-a16b-4df5-b0f4-6415417758e6 35 fields · synced 30 May 2026
  • EUDAMED 00195377051004|0193982SNONINVINSTJW 61 fields · synced 24 Oct 2026