NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM— 510(k) K090176

Name: FDA 510(k) clearance K090176
Creator: U.S. Food and Drug Administration
Published: 2009-04-27

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K090176 for NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM, Substantially Equivalent on 2009-04-27. Applicant: Nuvasive, Inc.. Device class: 2.

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2009-01-23
Decision date: 2009-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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K261810 — Vertiwedge® Intraosseous System2026-07-31
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K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Nuvasive, Inc.

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K240507 — NuVasive AttraX Scaffold2024-03-20
K223731 — NuVasive Modulus-C Interbody System2023-01-12
K211757 — Simplify Disc2021-08-20
K173117 — NuVasive® VersaTie System2017-12-07
K141665 — NuVasive CoRoent System2015-03-13

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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 →

Recalls naming K090176

K-number listed on FDA's recall record

Z-0738-2023 — X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.Class II·Ongoing·NuVasive Inc·20221110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090176.

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