FDA 510(k)

SURESHOT Distal Targeting System V4.0 Trauma Interface

K-Number: K170977 · 2017-05-03

Decision Date2017-05-03

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SURESHOT Distal Targeting System V4.0 Trauma Interface 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 2017-05-03 under 510(k) number K170977. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESHOT Distal Targeting System V4.0 Trauma Interface?

SURESHOT Distal Targeting System V4.0 Trauma Interface is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K170977.

When did SURESHOT Distal Targeting System V4.0 Trauma Interface receive FDA 510(k) clearance?

SURESHOT Distal Targeting System V4.0 Trauma Interface received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170977.

Who is the listed applicant for SURESHOT Distal Targeting System V4.0 Trauma Interface?

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 SURESHOT Distal Targeting System V4.0 Trauma Interface?

The FDA product code for SURESHOT Distal Targeting System V4.0 Trauma Interface is OLO.

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Other records listing Smith & Nephew, Inc. as applicant

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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.