510(k) K231841
K231841 is an FDA 510(k) premarket notification submitted by L&K BIOMED Co., Ltd. for the device "PathLoc SI Joint Fusion System". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. L&K BIOMED Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2023
- Date Received
- June 22, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sacroiliac Joint Fixation
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
sacroiliac joint fusion