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FDA 510(k)

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

K-Number: K112786 · 2011-10-25

ApplicantSynovis Orthopedic and Woundcare, Inc.
Decision Date2011-10-25
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Orthopedic and Woundcare, Inc.. It received FDA 510(k) clearance on 2011-10-25 under 510(k) number K112786. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF?

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Synovis Orthopedic and Woundcare, Inc.. The 510(k) number is K112786.

When did PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF receive FDA 510(k) clearance?

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF received FDA 510(k) clearance on 2011-10-25, under 510(k) number K112786.

Who is the listed applicant for PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF?

The FDA 510(k) record lists Synovis Orthopedic and Woundcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF?

The FDA product code for PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF is FTM.

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Related Devices (Code: FTM)

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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.

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