EXPANDABLE LUMBAR INTERBODY SYSTEM— 510(k) K130820

Clearance details

Applicant

Nu Vasive, Incorporated

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2013-03-25

Decision date

2013-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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• K230989 — Rod Registration Frame2023-05-05
• K223181 — NuVasive Reline System2023-01-11
• K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device2022-10-21

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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 →