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)

TISSUEMEND SOFT TISSUE REPAIR MATRIX

K-Number: K020455 · 2002-04-03

ApplicantTei Biosciences, Inc.
Decision Date2002-04-03
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TISSUEMEND SOFT TISSUE REPAIR MATRIX 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 2002-04-03 under 510(k) number K020455. 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 TISSUEMEND SOFT TISSUE REPAIR MATRIX?

TISSUEMEND SOFT TISSUE REPAIR MATRIX is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K020455.

When did TISSUEMEND SOFT TISSUE REPAIR MATRIX receive FDA 510(k) clearance?

TISSUEMEND SOFT TISSUE REPAIR MATRIX received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020455.

Who is the listed applicant for TISSUEMEND SOFT TISSUE REPAIR MATRIX?

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 TISSUEMEND SOFT TISSUE REPAIR MATRIX?

The FDA product code for TISSUEMEND SOFT TISSUE REPAIR MATRIX 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_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.

K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionK153690PriMatrix Dermal Repair ScaffoldK131286PRIMATRIX DERMAL REPAIR SCAFFOLDK100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDK083898SURGIMENDK083440PRIMATRIX DERMAL REPAIR SCAFFOLD

View all 16 devices →

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.

↑