FDA 510(k)

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

Numéro K : K192702 · 2020-09-18

Date de décision2020-09-18

Code produitGXN

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Source officielle

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