Stryker MP, Mandible, HMMF and MMF AXS Screws
FDA 510(k) K231599 · Stryker Leibinger GmbH & Co KG
510(k) numberK231599
Submission
- Device name
- Stryker MP, Mandible, HMMF and MMF AXS Screws
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg, DE - Received
- June 1, 2023
- Decision date
- August 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker MP, Mandible, HMMF and MMF AXS Screws cleared by the FDA?
Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599) received a 510(k) decision of Substantially Equivalent on August 24, 2023, 84 days after the submission was received.
What is the product code of K231599?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.