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)

MTA PROTECTIVE SHEET

K-Number: K090778 · 2009-04-28

ApplicantXylos Corporation
Decision Date2009-04-28
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MTA PROTECTIVE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Xylos Corporation. It received FDA 510(k) clearance on 2009-04-28 under 510(k) number K090778. 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 MTA PROTECTIVE SHEET?

MTA PROTECTIVE SHEET is a medical device that received FDA 510(k) clearance on 2009-04-28. The listed applicant is Xylos Corporation. The 510(k) number is K090778.

When did MTA PROTECTIVE SHEET receive FDA 510(k) clearance?

MTA PROTECTIVE SHEET received FDA 510(k) clearance on 2009-04-28, under 510(k) number K090778.

Who is the listed applicant for MTA PROTECTIVE SHEET?

The FDA 510(k) record lists Xylos Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTA PROTECTIVE SHEET?

The FDA product code for MTA PROTECTIVE SHEET 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 Xylos Corporation 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.

K111584XYLOS MACRO-POROUS SURGICAL MESHK100984XYLOS VESSEL GUARDK090880XYLOS POROUS SURGICAL MESHK083823SECURIAN TISSUE REINFORCEMENT MATRIXK081882MODIFICATION TO XYLOS SURGICAL MESHK023237XYLOS SURGICAL MESH

View all 9 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.

↑