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Precice Max System

by Nuvasive Specialized Orthopedics, Incorporated

510(k) K232267

Active United States

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232267 Date15 Dec 2023ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0500-2025 FDA Class II initiated 30 Sep 2024

    Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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