510(k) K162801
K162801 is an FDA 510(k) premarket notification submitted by L&K BIOMED Co., Ltd. for the device "CastleLoc Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on November 3, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. L&K BIOMED Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2016
- Date Received
- October 5, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spondylolisthesis Spinal Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type