Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) 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. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K162965.

When did SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction receive FDA 510(k) clearance?

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

Who is the listed applicant for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

The FDA 510(k) record lists Tei Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05081284Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen MatrixACTIVE_NOT_RECRUITINGNCT06335628Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen MatrixRECRUITINGNCT07185191Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)RECRUITINGNCT07219316Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer ExcisionCOMPLETEDNCT07713199Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)NOT_YET_RECRUITINGNCT07748871Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)NOT_YET_RECRUITING

Other records listing Tei Biosciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153690PriMatrix Dermal Repair Scaffold

Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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.

↑