FDA 510(k)

Vital Spinal Fixation System

K-Number: K253093 · 2025-12-17

Decision Date2025-12-17

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vital Spinal Fixation System is a medical device manufactured by Highridge Medical, LLC. It received FDA 510(k) clearance on 2025-12-17 under approval number K253093. 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 Vital Spinal Fixation System?

Vital Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Highridge Medical, LLC. The 510(k) number is K253093.

When was Vital Spinal Fixation System approved by the FDA?

Vital Spinal Fixation System received FDA 510(k) clearance on 2025-12-17, under approval number K253093.

What company makes Vital Spinal Fixation System?

Vital Spinal Fixation System is manufactured by Highridge Medical, LLC.

What is the FDA product code for Vital Spinal Fixation System?

The FDA product code for Vital Spinal Fixation System is NKB.

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Related PubMed Literature

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Other Devices by Highridge Medical, LLC

K250332Virage® OCT Spinal Fixation System PMA P110002Prosthesis, intervertebral disc PMA P110009Prosthesis, intervertebral disc PMA P120024Prosthesis, intervertebral disc

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.