FDA 510(k)

Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology

K-Number: K241605 · 2024-09-05

Decision Date2024-09-05

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2024-09-05 under approval number K241605. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology?

Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology is a medical device that received FDA 510(k) clearance on 2024-09-05. It is manufactured by Nanovis, LLC. The 510(k) number is K241605.

When was Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology approved by the FDA?

Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology received FDA 510(k) clearance on 2024-09-05, under approval number K241605.

What company makes Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology?

Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology is manufactured by Nanovis, LLC.

What is the FDA product code for Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology?

The FDA product code for Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology is MAX.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Nanovis, LLC

K161485Nanovis Intervertebral Body Fusion System and Forticore(R) K160874Nanovis Intervertebral Body Fusion System and FortiCore® K171312FortiCore® K191822Nano FortiCore, FortiCore K203452Nano FortiFix® System K230936Anatomic PEEK Cervical Fusion System with Nanotechnology

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.