DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
FDA 510(k) K192702 · Synthes (USA) Products, LLC
510(k) numberK192702
Submission
- Device name
- DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- September 27, 2019
- Decision date
- September 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional cleared by the FDA?
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (K192702) received a 510(k) decision of Substantially Equivalent on September 18, 2020, 357 days after the submission was received.
What is the product code of K192702?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.