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FDA 510(k)

Annex® 2 Adjacent Level System

K-Number: K251131 · 2025-06-06

ApplicantSpine Wave, Inc.
Decision Date2025-06-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Annex® 2 Adjacent Level System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2025-06-06 under approval number K251131. 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 Annex® 2 Adjacent Level System?

Annex® 2 Adjacent Level System is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Spine Wave, Inc.. The 510(k) number is K251131.

When was Annex® 2 Adjacent Level System approved by the FDA?

Annex® 2 Adjacent Level System received FDA 510(k) clearance on 2025-06-06, under approval number K251131.

What company makes Annex® 2 Adjacent Level System?

Annex® 2 Adjacent Level System is manufactured by Spine Wave, Inc..

What is the FDA product code for Annex® 2 Adjacent Level System?

The FDA product code for Annex® 2 Adjacent Level System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Spine Wave, Inc.

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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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