510(k) K181600
K181600 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 Jul 16, 2018. 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 57 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 16, 2018
- Date Received
- Jun 18, 2018
- 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
- 510(k)
sacroiliac joint fusion