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FDA 510(k)

SURESHOT Distal Targeting System V4.0 Trauma Interface

K-Number: K170977 · 2017-05-03

ApplicantSmith & Nephew, Inc.
Decision Date2017-05-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

When was SURESHOT Distal Targeting System V4.0 Trauma Interface approved by the FDA?

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

What company makes SURESHOT Distal Targeting System V4.0 Trauma Interface?

SURESHOT Distal Targeting System V4.0 Trauma Interface is manufactured by Smith & Nephew, Inc..

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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Related PubMed Literature

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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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