Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology— 510(k) K241605

Name: FDA 510(k) clearance K241605
Creator: U.S. Food and Drug Administration
Published: 2024-09-05

Substantially Equivalent

Nanovis, LLC

FDA 510(k) clearance K241605 for Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology, Substantially Equivalent on 2024-09-05. Applicant: Nanovis, LLC. Device class: 2.

Clearance details

Applicant: Nanovis, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-06-04
Decision date: 2024-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia City, IN, US

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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K230936 — Anatomic PEEK Cervical Fusion System with Nanotechnology2023-06-02
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K171312 — FortiCore®2018-01-22
K161485 — Nanovis Intervertebral Body Fusion System and Forticore(R)2016-09-06

Adverse events under product code MAX

product code MAX

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 →

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