FDA 510(k)

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

K-Number: K190963 · 2019-07-23

Decision Date2019-07-23

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-07-23 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K190963.

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

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

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

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

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.

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: 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.