Submission Details
| 510(k) Number | K192702 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2019 |
| Decision Date | September 18, 2020 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
Sep 2020
Decision
357d
Days
Class 2
Risk
About This 510(k) Submission
K192702 is an FDA 510(k) clearance for the DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on September 18, 2020, 357 days after receiving the submission on September 27, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.
Device Classification
| Product Code | GXN — Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5330 |
Manufacturer
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