510(k) K242650
K242650 is an FDA 510(k) premarket notification submitted by Zygofix , Ltd. for the device "zLOCK Lumbar Facet Fixation System". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Zygofix , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2024
- Date Received
- September 4, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type