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FDA 510(k)

Adaptable Ortho Innovations Intramedullary Nail System

K-Number: K210285 · 2021-03-18

ApplicantAdaptable Ortho Innovations, LLC
Decision Date2021-03-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adaptable Ortho Innovations Intramedullary Nail System is a medical device manufactured by Adaptable Ortho Innovations, LLC. It received FDA 510(k) clearance on 2021-03-18 under approval number K210285. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adaptable Ortho Innovations Intramedullary Nail System?

Adaptable Ortho Innovations Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2021-03-18. It is manufactured by Adaptable Ortho Innovations, LLC. The 510(k) number is K210285.

When was Adaptable Ortho Innovations Intramedullary Nail System approved by the FDA?

Adaptable Ortho Innovations Intramedullary Nail System received FDA 510(k) clearance on 2021-03-18, under approval number K210285.

What company makes Adaptable Ortho Innovations Intramedullary Nail System?

Adaptable Ortho Innovations Intramedullary Nail System is manufactured by Adaptable Ortho Innovations, LLC.

What is the FDA product code for Adaptable Ortho Innovations Intramedullary Nail System?

The FDA product code for Adaptable Ortho Innovations Intramedullary Nail System is HSB.

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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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