FDA 510(k)

CAPTIVATE Compression Screws

K-Number: K162825 · 2017-05-01

Decision Date2017-05-01

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CAPTIVATE Compression Screws is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval number K162825. 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 CAPTIVATE Compression Screws?

CAPTIVATE Compression Screws is a medical device that received FDA 510(k) clearance on 2017-05-01. It is manufactured by Globus Medical, Inc.. The 510(k) number is K162825.

When was CAPTIVATE Compression Screws approved by the FDA?

CAPTIVATE Compression Screws received FDA 510(k) clearance on 2017-05-01, under approval number K162825.

What company makes CAPTIVATE Compression Screws?

CAPTIVATE Compression Screws is manufactured by Globus Medical, Inc..

What is the FDA product code for CAPTIVATE Compression Screws?

The FDA product code for CAPTIVATE Compression Screws is HWC. This falls under the Cardiovascular category.

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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.