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FDA 510(k)

Addivation Medical Cervical Interbody System

K-Number: K190291 · 2019-07-30

ApplicantAddivation Medical, LLC
Decision Date2019-07-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Addivation Medical Cervical Interbody System is a medical device manufactured by Addivation Medical, LLC. It received FDA 510(k) clearance on 2019-07-30 under approval number K190291. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Addivation Medical Cervical Interbody System?

Addivation Medical Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2019-07-30. It is manufactured by Addivation Medical, LLC. The 510(k) number is K190291.

When was Addivation Medical Cervical Interbody System approved by the FDA?

Addivation Medical Cervical Interbody System received FDA 510(k) clearance on 2019-07-30, under approval number K190291.

What company makes Addivation Medical Cervical Interbody System?

Addivation Medical Cervical Interbody System is manufactured by Addivation Medical, LLC.

What is the FDA product code for Addivation Medical Cervical Interbody System?

The FDA product code for Addivation Medical Cervical Interbody System is ODP.

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Related Devices (Code: ODP)

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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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