510(k) K190696
K190696 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Surgeon iD Mandible Recon Plate". The FDA issued a decision of Substantially Equivalent on Jun 28, 2019. 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
- Jun 28, 2019
- Date Received
- Mar 18, 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)