510(k) K163440
K163440 is an FDA 510(k) premarket notification submitted by First Ray, LLC for the device "Stealth Staple System". The FDA issued a decision of Substantially Equivalent on Feb 1, 2017. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. First Ray, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2017
- Date Received
- Dec 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)