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FDA 510(k)

DePuy Synthes 2.0 mm Quick Insertion Screws

K-Number: K180541 · 2018-11-21

ApplicantSynthes USA Products, LLC
Decision Date2018-11-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes 2.0 mm Quick Insertion Screws is a medical device manufactured by Synthes USA Products, LLC. It received FDA 510(k) clearance on 2018-11-21 under approval number K180541. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes 2.0 mm Quick Insertion Screws?

DePuy Synthes 2.0 mm Quick Insertion Screws is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Synthes USA Products, LLC. The 510(k) number is K180541.

When was DePuy Synthes 2.0 mm Quick Insertion Screws approved by the FDA?

DePuy Synthes 2.0 mm Quick Insertion Screws received FDA 510(k) clearance on 2018-11-21, under approval number K180541.

What company makes DePuy Synthes 2.0 mm Quick Insertion Screws?

DePuy Synthes 2.0 mm Quick Insertion Screws is manufactured by Synthes USA Products, LLC.

What is the FDA product code for DePuy Synthes 2.0 mm Quick Insertion Screws?

The FDA product code for DePuy Synthes 2.0 mm Quick Insertion Screws is HWC. This falls under the Cardiovascular category.

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) K170654USS System 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

Related Devices (Code: HWC)

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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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