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FDA 510(k)

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

K-Number: K192702 · 2020-09-18

ApplicantSynthes (USA) Products, LLC
Decision Date2020-09-18
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-09-18 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K192702.

When was DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional approved by the FDA?

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

What company makes DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional?

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional is manufactured by Synthes (USA) Products, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 39963190 Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices. Frontiers in medical technology (2025)

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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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