510(k) K193136
K193136 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Customized Mandible Recon Plate Kit". The FDA issued a decision of Substantially Equivalent on Mar 26, 2020. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 26, 2020
- Date Received
- Nov 13, 2019
- 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
- 510(k)