Rod Registration Frame— 510(k) K230989

Clearance details

Applicant

Nu Vasive, Incorporated

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2023-04-06

Decision date

2023-05-05

Decision

Substantially Equivalent

Clearance type

Special

Location

San Diego, CA, US

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• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K231735 — NuVasive CoRoent Small Interbody System +5 more2023-07-11
• K230894 — NuVasive Modulus ALIF System2023-06-16
• K223181 — NuVasive Reline System2023-01-11
• K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device2022-10-21
• K221388 — NuVasive Reline Cervical System2022-09-09

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →