510(k) K190425
K190425 is an FDA 510(k) premarket notification submitted by L&K BIOMED Co., Ltd. for the device "CastleLoc-P Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Mar 21, 2019. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. L&K BIOMED Co., Ltd. has 57 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 21, 2019
- Date Received
- Feb 22, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)