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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 the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) 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. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K183472.

When did DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional receive FDA 510(k) clearance?

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

Who is the listed applicant for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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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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