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FDA 510(k)

CAPTIVATE® Compression Screws

K-Number: K222409 · 2022-09-08

ApplicantGlobus Medical, Inc.
Decision Date2022-09-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPTIVATE® Compression Screws is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K222409. 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 2022-09-08. The listed applicant is Globus Medical, Inc.. The 510(k) number is K222409.

When did CAPTIVATE® Compression Screws receive FDA 510(k) clearance?

CAPTIVATE® Compression Screws received FDA 510(k) clearance on 2022-09-08, under 510(k) number K222409.

Who is the listed applicant for CAPTIVATE® Compression Screws?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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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