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FDA 510(k)

STROPP (Single Tunnel Repair of Plantar Plate)

K-Number: K160118 · 2016-05-03

Decision Date2016-05-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STROPP (Single Tunnel Repair of Plantar Plate) is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2016-05-03 under approval number K160118. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STROPP (Single Tunnel Repair of Plantar Plate)?

STROPP (Single Tunnel Repair of Plantar Plate) is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K160118.

When was STROPP (Single Tunnel Repair of Plantar Plate) approved by the FDA?

STROPP (Single Tunnel Repair of Plantar Plate) received FDA 510(k) clearance on 2016-05-03, under approval number K160118.

What company makes STROPP (Single Tunnel Repair of Plantar Plate)?

STROPP (Single Tunnel Repair of Plantar Plate) is manufactured by Crossroads Extremity Systems, LLC.

What is the FDA product code for STROPP (Single Tunnel Repair of Plantar Plate)?

The FDA product code for STROPP (Single Tunnel Repair of Plantar Plate) is MBI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.