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FDA 510(k)

InstaFill Graft Delivery System, SIGNIFY Bioactive

K-Number: K221737 · 2022-08-11

ApplicantGlobus Medical, Inc.
Decision Date2022-08-11
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

InstaFill Graft Delivery System, SIGNIFY Bioactive is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K221737. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstaFill Graft Delivery System, SIGNIFY Bioactive?

InstaFill Graft Delivery System, SIGNIFY Bioactive is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Globus Medical, Inc.. The 510(k) number is K221737.

When was InstaFill Graft Delivery System, SIGNIFY Bioactive approved by the FDA?

InstaFill Graft Delivery System, SIGNIFY Bioactive received FDA 510(k) clearance on 2022-08-11, under approval number K221737.

What company makes InstaFill Graft Delivery System, SIGNIFY Bioactive?

InstaFill Graft Delivery System, SIGNIFY Bioactive is manufactured by Globus Medical, Inc..

What is the FDA product code for InstaFill Graft Delivery System, SIGNIFY Bioactive?

The FDA product code for InstaFill Graft Delivery System, SIGNIFY Bioactive is FMF.

Related Clinical Trials

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Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

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

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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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