NuVasive Modulus-C Interbody System— 510(k) K223731

Name: FDA 510(k) clearance K223731
Creator: U.S. Food and Drug Administration
Published: 2023-01-12

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K223731 for NuVasive Modulus-C Interbody System, Substantially Equivalent on 2023-01-12. Applicant: Nuvasive, Inc.. Device class: 2.

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-12-13
Decision date: 2023-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Nuvasive, Inc.

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K240507 — NuVasive AttraX Scaffold2024-03-20
K211757 — Simplify Disc2021-08-20
K173117 — NuVasive® VersaTie System2017-12-07
K141665 — NuVasive CoRoent System2015-03-13
K142205 — NuVasive X-CORE(R) Expandable VBR System2015-02-20

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.