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FDA 510(k)

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

K-Number: K162965 · 2017-02-16

ApplicantTei Biosciences, Inc.
Decision Date2017-02-16
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is a medical device manufactured by Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K162965. 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 SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Tei Biosciences, Inc.. The 510(k) number is K162965.

When was SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction approved by the FDA?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction received FDA 510(k) clearance on 2017-02-16, under approval number K162965.

What company makes SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is manufactured by Tei Biosciences, Inc..

What is the FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

The FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is FTM.

Related Clinical Trials

NCT07431099 Skin Color Matching in Head and Neck Reconstructive Surgery RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED

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: 40001655 Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Tei Biosciences, Inc.

K153690PriMatrix Dermal Repair Scaffold

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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