K253374
- 510(k) number
- K253374
- Device name
- LimiFlex® Dynamic Sagittal Tether Instrument Set
- Applicant
- Empirical Spine CA · US
- Product code
- SGL — Manual Instruments Designed For Use With Non-Fusion
- Decision date
- 2026-06-16
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253374.pdf
Official FDA record: K253374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.