510(k) K153638
K153638 is an FDA 510(k) premarket notification submitted by First Ray, LLC for the device "Bicortical Fixation Screw & Washer Nut System". The FDA issued a decision of Substantially Equivalent on Apr 19, 2016. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. First Ray, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2016
- Date Received
- Dec 18, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)