Submission Details
| 510(k) Number | K191916 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2019 |
| Decision Date | August 15, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Special
Stryker CMF MEDPOR Priority Customized Implant Kit
Aug 2019
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K191916 is an FDA 510(k) clearance for the Stryker CMF MEDPOR Priority Customized Implant Kit, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on August 15, 2019, 29 days after receiving the submission on July 17, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
Device Classification
| Product Code | FWP — Prosthesis, Chin, Internal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3550 |
Manufacturer
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