Submission Details
| 510(k) Number | K231599 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2023 |
| Decision Date | August 24, 2023 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Stryker MP, Mandible, HMMF and MMF AXS Screws
Aug 2023
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K231599 is an FDA 510(k) clearance for the Stryker MP, Mandible, HMMF and MMF AXS Screws, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on August 24, 2023, 84 days after receiving the submission on June 1, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.
Device Classification
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4880 |
Manufacturer
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