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

FDA 510(k)

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional

K-Number: K183472 · 2019-03-13

ApplicantSynthes (USA) Products, LLC
Decision Date2019-03-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under approval number K183472. 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 DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is a medical device that received FDA 510(k) clearance on 2019-03-13. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K183472.

When was DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional approved by the FDA?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional received FDA 510(k) clearance on 2019-03-13, under approval number K183472.

What company makes DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

The FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is FTM.

Related Clinical Trials

NCT06430268 Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants ENROLLING_BY_INVITATION NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING

Other Devices by Synthes (USA) Products, LLC

K161590MatrixRIB Fixation System K160167DePuy Synthes TFNA Augmentation System K172157DePuy Synthes Femoral Recon Nail System K170802TRAUMACEM™ V+ Injectable Bone Cement K153587Taps for Resorbable Screws K180213Titanium TomoFix Medial High Tibia Plate Anatomical

View all 23 devices →

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.

↑