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Pulse 1802493

by NuVasive, LLC

Pulse 1802493 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K210574 on 29 Jul 2021 and listed in FDA GUDID since 6 May 2022 (UDI-DI 00195377065520), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K210574

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00195377065520 UDI-DI Date6 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210574 Date29 Jul 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210574 decided 29 Jul 2021 Active
  • FDA GUDID UDI-DI 00195377065520 listed 6 May 2022 Listed

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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K210574
  2. Listed FDA GUDID 00195377065520
  3. Recall initiated FDA recalls Z-1052-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pulse
Generic name
Orthopaedic stereotactic surgery system
Model / reference
1802493
Primary DI / UDI-DI
00195377065520
510(k) Number
FDA product code
OLO, OWB, PDQ, IKN, LLZ, ETN, JAA, GWF, HAW
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class II
Regulation number
882.4560, 892.1650, 874.1820, 890.1375, 892.2050, 882.1870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic stereotactic surgery system

Cleared under the same submission (K210574)

and 8 more cleared under K210574

Similar devices in this category

Other devices filed under Orthopaedic stereotactic surgery system.

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See all devices from NuVasive, LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)