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FDA 510(k)

A.M. Surgical Intramedullary Fixation Device

K-Number: K180087 · 2018-05-18

ApplicantA.M. Surgical, Inc.
Decision Date2018-05-18
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A.M. Surgical Intramedullary Fixation Device is a medical device manufactured by A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180087. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.M. Surgical Intramedullary Fixation Device?

A.M. Surgical Intramedullary Fixation Device is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by A.M. Surgical, Inc.. The 510(k) number is K180087.

When was A.M. Surgical Intramedullary Fixation Device approved by the FDA?

A.M. Surgical Intramedullary Fixation Device received FDA 510(k) clearance on 2018-05-18, under approval number K180087.

What company makes A.M. Surgical Intramedullary Fixation Device?

A.M. Surgical Intramedullary Fixation Device is manufactured by A.M. Surgical, Inc..

What is the FDA product code for A.M. Surgical Intramedullary Fixation Device?

The FDA product code for A.M. Surgical Intramedullary Fixation Device is HTY.

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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: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. 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)

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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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