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)

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

K-Number: K192702 · 2020-09-18

Decision Date2020-09-18
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Craniomaxillofacial Neuro 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 2020-09-18 under 510(k) number K192702. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K192702.

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

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional received FDA 510(k) clearance on 2020-09-18, under 510(k) number K192702.

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

The FDA product code for DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is GXN.

Other records listing Synthes (USA) Products, LLC 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.

View all 30 devices →

Related Devices (Code: GXN)

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.

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.