FDA 510(k)

LOCK-IN Spinal Fixation System

K-Number: K243281 · 2024-12-13

Decision Date2024-12-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LOCK-IN Spinal Fixation System is a medical device manufactured by Lock-In USA Corp. It received FDA 510(k) clearance on 2024-12-13 under approval number K243281. 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 LOCK-IN Spinal Fixation System?

LOCK-IN Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Lock-In USA Corp. The 510(k) number is K243281.

When was LOCK-IN Spinal Fixation System approved by the FDA?

LOCK-IN Spinal Fixation System received FDA 510(k) clearance on 2024-12-13, under approval number K243281.

What company makes LOCK-IN Spinal Fixation System?

LOCK-IN Spinal Fixation System is manufactured by Lock-In USA Corp.

What is the FDA product code for LOCK-IN Spinal Fixation System?

The FDA product code for LOCK-IN Spinal Fixation 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

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