510(k) K190172
K190172 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments". The FDA issued a decision of Substantially Equivalent on Jun 14, 2019. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2019
- Date Received
- Feb 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type
- 510(k)