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FDA 510(k)

TRIGEN Low Profile Bone Screws

K-Number: K161264 · 2016-11-23

ApplicantSmith & Nephew, Inc.
Decision Date2016-11-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIGEN Low Profile Bone Screws is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-23 under approval 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. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K161264.

When was TRIGEN Low Profile Bone Screws approved by the FDA?

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

What company makes TRIGEN Low Profile Bone Screws?

TRIGEN Low Profile Bone Screws is manufactured by Smith & Nephew, Inc..

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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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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