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FDA 510(k)

DePuy Synthes TFNA Augmentation System

K-Number: K160167 · 2016-09-26

ApplicantSynthes (USA) Products, LLC
Decision Date2016-09-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes TFNA Augmentation System is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2016-09-26 under approval number K160167. 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 DePuy Synthes TFNA Augmentation System?

DePuy Synthes TFNA Augmentation System is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K160167.

When was DePuy Synthes TFNA Augmentation System approved by the FDA?

DePuy Synthes TFNA Augmentation System received FDA 510(k) clearance on 2016-09-26, under approval number K160167.

What company makes DePuy Synthes TFNA Augmentation System?

DePuy Synthes TFNA Augmentation System is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for DePuy Synthes TFNA Augmentation System?

The FDA product code for DePuy Synthes TFNA Augmentation System is HSB.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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