AFFIX SPINOUS PROCESS PLATE SYSTEM— 510(k) K131238

Name: FDA 510(k) clearance K131238
Creator: U.S. Food and Drug Administration
Published: 2013-07-02

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K131238 for AFFIX SPINOUS PROCESS PLATE SYSTEM, Substantially Equivalent on 2013-07-02. Applicant: Nuvasive, Inc.. Device class: 2.

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-05-01
Decision date: 2013-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEK

view all

K253250 — Minuteman® G6 MIS Fusion Plate2025-12-01
K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18
K233527 — Minuteman G5 MIS Fusion Plate +3 more2023-11-29
K232484 — KeyLift Expandable Interlaminar Stabilization System2023-10-19
K231807 — primaLOK SP Interspinous Fusion System2023-08-15

More clearances from Nuvasive, Inc.

view all

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

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