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FDA 510(k)

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

K-Number: K190963 · 2019-07-23

ApplicantSynthes (USA) Products, LLC
Decision Date2019-07-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Craniomaxillofacial Sternal Devices - 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 2019-07-23 under 510(k) number K190963. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional?

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is a medical device that received FDA 510(k) clearance on 2019-07-23. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K190963.

When did DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional received FDA 510(k) clearance on 2019-07-23, under 510(k) number K190963.

Who is the listed applicant for DePuy Synthes Craniomaxillofacial Sternal Devices - 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 Craniomaxillofacial Sternal Devices - MR Conditional?

The FDA product code for DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is HRS.

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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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