FDA 510(k)

TRIGEN Low Profile Bone Screws

K-Number: K161264 · 2016-11-23

Decision Date2016-11-23

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRIGEN Low Profile Bone Screws 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 2016-11-23 under 510(k) number K161264. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGEN Low Profile Bone Screws?

TRIGEN Low Profile Bone Screws is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161264.

When did TRIGEN Low Profile Bone Screws receive FDA 510(k) clearance?

TRIGEN Low Profile Bone Screws received FDA 510(k) clearance on 2016-11-23, under 510(k) number K161264.

Who is the listed applicant for TRIGEN Low Profile Bone Screws?

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 TRIGEN Low Profile Bone Screws?

The FDA product code for TRIGEN Low Profile Bone Screws is HSB.

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Other records listing Smith & Nephew, Inc. as applicant

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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.