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FDA 510(k)

ARTIA Reconstructive Tissue Matrix Perforated

K-Number: K162752 · 2017-02-24

ApplicantLifecell Corporation
Decision Date2017-02-24
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTIA Reconstructive Tissue Matrix Perforated is a medical device manufactured by Lifecell Corporation. It received FDA 510(k) clearance on 2017-02-24 under approval number K162752. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIA Reconstructive Tissue Matrix Perforated?

ARTIA Reconstructive Tissue Matrix Perforated is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Lifecell Corporation. The 510(k) number is K162752.

When was ARTIA Reconstructive Tissue Matrix Perforated approved by the FDA?

ARTIA Reconstructive Tissue Matrix Perforated received FDA 510(k) clearance on 2017-02-24, under approval number K162752.

What company makes ARTIA Reconstructive Tissue Matrix Perforated?

ARTIA Reconstructive Tissue Matrix Perforated is manufactured by Lifecell Corporation.

What is the FDA product code for ARTIA Reconstructive Tissue Matrix Perforated?

The FDA product code for ARTIA Reconstructive Tissue Matrix Perforated is FTM.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41972695 Glycerol-Based Cryopreservation of CELT-Fat: Identification of the Optimal Concentration in a GMP-Compatible Protocol. Cells (2026) PMID: 40001655 Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Lifecell Corporation

K163647Revolve Envi 600 Advanced Adipose System K193539REVOLVE ENVI 600 Advanced Adipose System

Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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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