FDA 510(k)

FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL

K-Number: K123579 · 2013-01-23

Decision Date2013-01-23

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K123579. 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 FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL?

FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K123579.

When did FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL receive FDA 510(k) clearance?

FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL received FDA 510(k) clearance on 2013-01-23, under 510(k) number K123579.

Who is the listed applicant for FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL?

The FDA product code for FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL is MBI.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: MBI)

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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.