Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-08 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K222409.

When was CAPTIVATE® Compression Screws approved by the FDA?

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

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.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

View all 91 devices →

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

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.

↑