510(k) K231599
K231599 is an FDA 510(k) premarket notification submitted by Stryker Leibinger GmbH & Co KG for the device "Stryker MP, Mandible, HMMF and MMF AXS Screws". The FDA issued a decision of Substantially Equivalent on August 24, 2023. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Stryker Leibinger GmbH & Co KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2023
- Date Received
- June 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type