510(k) K213777
K213777 is an FDA 510(k) premarket notification submitted by Stryker Leibinger Micro Implants for the device "Stryker Resorbable Fixation System". The FDA issued a decision of Substantially Equivalent on February 4, 2022. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Stryker Leibinger Micro Implants has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2022
- Date Received
- December 3, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type