← Back to catalogue

SpineVu Endoscopic Spine System (SESS)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113362

by Spine View, Inc.

Identifiers

510(k) Number
K113362 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SpineVu Endoscopic Spine System (SESS) is an arthroscope designed for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine. It is accessorized with surgical and coagulation tools to perform interventional spinal procedures, including discectomy, nucleotomy, and foraminotomy, as well as surgery within a joint.

This system is supplied for use in minimally invasive spinal surgery. It has received FDA 510(k) clearance under K113362. Users should refer to the manufacturer's instructions for specific details regarding storage, sterility, and the intended use of individual components.

Frequently asked questions

What is the primary clinical application of the SpineVu Endoscopic Spine System?

The system is an arthroscope used for endoscopic access and visualization within the cervical, thoracic, or lumbar spine. It is equipped with surgical and coagulation tools to facilitate interventional procedures such as discectomy, nucleotomy, foraminotomy, and surgery within a joint.

What is the regulatory status of this system?

The SpineVu Endoscopic Spine System has received FDA 510(k) clearance under K113362. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Where can I find specific information regarding the sterility and storage of the device?

Users should refer directly to the manufacturer's instructions provided by Spine View, Inc. These documents contain the necessary details regarding the proper storage conditions, sterility requirements, and intended use for each individual component of the system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope, SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K121548) — FDA 510 (k) | Innolitics, K121548 FDA 510(k) - SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spine View, Inc.

Sources (1)

  • FDA 510(k) K113362 24 fields · synced Sep 22, 2026