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FDA 510(k)

Foundation Dermal Regeneration Scaffold (DRS) Solo

K-Number: K210949 · 2022-08-11

ApplicantBionova Medical, Inc.
Decision Date2022-08-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Foundation Dermal Regeneration Scaffold (DRS) Solo is a medical device manufactured by Bionova Medical, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K210949. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foundation Dermal Regeneration Scaffold (DRS) Solo?

Foundation Dermal Regeneration Scaffold (DRS) Solo is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Bionova Medical, Inc.. The 510(k) number is K210949.

When was Foundation Dermal Regeneration Scaffold (DRS) Solo approved by the FDA?

Foundation Dermal Regeneration Scaffold (DRS) Solo received FDA 510(k) clearance on 2022-08-11, under approval number K210949.

What company makes Foundation Dermal Regeneration Scaffold (DRS) Solo?

Foundation Dermal Regeneration Scaffold (DRS) Solo is manufactured by Bionova Medical, Inc..

What is the FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo?

The FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo is KGN.

Related Clinical Trials

NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING

Related PubMed Literature

PMID: 39933996 Micro/Nanobiomimetic Iron-Based Scaffold Induces Vascularized Bone Regeneration To Repair Large Segmental Bone Defect in Load-Bearing Sites. ACS nano (2025)

Other Devices by Bionova Medical, Inc.

K231937Foundation Dermal Regeneration Scaffold (DRS) Solo K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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