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FDA 510(k)

USS System

K-Number: K170654 · 2017-03-29

ApplicantSynthes USA Products, LLC
Decision Date2017-03-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

USS System is a medical device manufactured by Synthes USA Products, LLC. It received FDA 510(k) clearance on 2017-03-29 under approval number K170654. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USS System?

USS System is a medical device that received FDA 510(k) clearance on 2017-03-29. It is manufactured by Synthes USA Products, LLC. The 510(k) number is K170654.

When was USS System approved by the FDA?

USS System received FDA 510(k) clearance on 2017-03-29, under approval number K170654.

What company makes USS System?

USS System is manufactured by Synthes USA Products, LLC.

What is the FDA product code for USS System?

The FDA product code for USS System is NKB.

Other Devices by Synthes USA Products, LLC

K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System K170818Craniomaxillofacial Distraction System (CMFD) K162594Craniomaxillofacial Distraction System (CMFD) K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw K180541DePuy Synthes 2.0 mm Quick Insertion Screws

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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.

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