K240085
- 510(k) number
- K240085
- Device name
- zLOCK Lumbar Facet Fixation System
- Applicant
- Zygofix , Ltd. IL
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2024-04-18
- Date received
- 2024-01-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240085.pdf
Official FDA record: K240085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.