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FDA 510(k)

FORTEZZA Spinal Stabilization System

K-Number: K162576 · 2016-11-10

ApplicantOsso Surgical
Decision Date2016-11-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTEZZA Spinal Stabilization System is a medical device manufactured by Osso Surgical. It received FDA 510(k) clearance on 2016-11-10 under approval number K162576. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTEZZA Spinal Stabilization System?

FORTEZZA Spinal Stabilization System is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Osso Surgical. The 510(k) number is K162576.

When was FORTEZZA Spinal Stabilization System approved by the FDA?

FORTEZZA Spinal Stabilization System received FDA 510(k) clearance on 2016-11-10, under approval number K162576.

What company makes FORTEZZA Spinal Stabilization System?

FORTEZZA Spinal Stabilization System is manufactured by Osso Surgical.

What is the FDA product code for FORTEZZA Spinal Stabilization System?

The FDA product code for FORTEZZA Spinal Stabilization System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: NKB)

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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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