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FDA 510(k)

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

K-Number: K241605 · 2024-09-05

ApplicantNanovis, LLC
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 the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2024-09-05 under 510(k) 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. The listed applicant is Nanovis, LLC. The 510(k) number is K241605.

When did Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology receive FDA 510(k) clearance?

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

Who is the listed applicant for Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology?

The FDA 510(k) record lists Nanovis, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Nanovis, LLC as applicant

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K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyK203452Nano FortiFix® SystemK191822Nano FortiCore, FortiCoreK171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)K160874Nanovis Intervertebral Body Fusion System and FortiCore®

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.

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