CastleLoc-P Anterior Cervical Plate System— 510(k) K261112
Substantially EquivalentL&K BIOMED Co., Ltd.
FDA 510(k) clearance K261112 for CastleLoc-P Anterior Cervical Plate System, Substantially Equivalent on 2026-05-06. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.
Summary
L&K BIOMED's CastleLoc-P Anterior Cervical Plate System is filed under KWQ, spinal intervertebral body fixation appliances.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
L&K BIOMED filed from Yongin-Si, South Korea. Review took 33 calendar days (April 3 to May 6, 2026).
Clearance details
- Applicant
- L&K BIOMED Co., Ltd.
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yongin-Si, KR
Recent devices under product code KWQ
view allMore clearances from L&K BIOMED Co., Ltd.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.