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FDA 510(k)

PriMatrix Dermal Repair Scaffold

K-Number: K153690 · 2016-02-22

ApplicantTei Biosciences, Inc.
Decision Date2016-02-22
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

PriMatrix Dermal Repair Scaffold is a medical device manufactured by Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2016-02-22 under approval number K153690. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PriMatrix Dermal Repair Scaffold?

PriMatrix Dermal Repair Scaffold is a medical device that received FDA 510(k) clearance on 2016-02-22. It is manufactured by Tei Biosciences, Inc.. The 510(k) number is K153690.

When was PriMatrix Dermal Repair Scaffold approved by the FDA?

PriMatrix Dermal Repair Scaffold received FDA 510(k) clearance on 2016-02-22, under approval number K153690.

What company makes PriMatrix Dermal Repair Scaffold?

PriMatrix Dermal Repair Scaffold is manufactured by Tei Biosciences, Inc..

What is the FDA product code for PriMatrix Dermal Repair Scaffold?

The FDA product code for PriMatrix Dermal Repair Scaffold is KGN.

Related Clinical Trials

NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING NCT07101562 Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head RECRUITING NCT04325789 Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years COMPLETED NCT02659215 HyaloFAST Trial for Repair of Articular Cartilage in the Knee ACTIVE_NOT_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 Tei Biosciences, Inc.

K162965SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG K172399MicroMatrixAcell, Inc.

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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