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FDA 510(k)

Smith & Nephew SURESHOT Distal Targeting System V4.0

K-Number: K170280 · 2017-04-28

ApplicantSmith & Nephew, Inc.
Decision Date2017-04-28
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smith & Nephew SURESHOT Distal Targeting System V4.0 is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-04-28 under approval number K170280. 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 Smith & Nephew SURESHOT Distal Targeting System V4.0?

Smith & Nephew SURESHOT Distal Targeting System V4.0 is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K170280.

When was Smith & Nephew SURESHOT Distal Targeting System V4.0 approved by the FDA?

Smith & Nephew SURESHOT Distal Targeting System V4.0 received FDA 510(k) clearance on 2017-04-28, under approval number K170280.

What company makes Smith & Nephew SURESHOT Distal Targeting System V4.0?

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

What is the FDA product code for Smith & Nephew SURESHOT Distal Targeting System V4.0?

The FDA product code for Smith & Nephew SURESHOT Distal Targeting System V4.0 is OLO.

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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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