510(k) K161334
K161334 is an FDA 510(k) premarket notification submitted by Radicle Orthopaedics, Inc. for the device "RASL Repair Kit". The FDA issued a decision of Substantially Equivalent on Feb 9, 2017. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 2017
- Date Received
- May 12, 2016
- 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)