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FDA 510(k)

Shotel Ankle Arthrodesis Nail System

K-Number: K163627 · 2017-09-14

ApplicantBiopro, Inc.
Decision Date2017-09-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shotel Ankle Arthrodesis Nail System is a medical device manufactured by Biopro, Inc.. It received FDA 510(k) clearance on 2017-09-14 under approval number K163627. 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 Shotel Ankle Arthrodesis Nail System?

Shotel Ankle Arthrodesis Nail System is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Biopro, Inc.. The 510(k) number is K163627.

When was Shotel Ankle Arthrodesis Nail System approved by the FDA?

Shotel Ankle Arthrodesis Nail System received FDA 510(k) clearance on 2017-09-14, under approval number K163627.

What company makes Shotel Ankle Arthrodesis Nail System?

Shotel Ankle Arthrodesis Nail System is manufactured by Biopro, Inc..

What is the FDA product code for Shotel Ankle Arthrodesis Nail System?

The FDA product code for Shotel Ankle Arthrodesis Nail System is HSB.

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Other Devices by Biopro, Inc.

K162674BioPro Foot Plating Systems

Related Devices (Code: 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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