FDA 510(k)
Substantially Equivalent
🇺🇸 United States
LimiFlex® Dynamic Sagittal Tether Instrument Set
K Number: K253374
·
Decision Jun 16, 2026
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
1
Review Days
259
Basic Information
- Device Name
- LimiFlex® Dynamic Sagittal Tether Instrument Set
- K Number
- K253374
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empirical Spine
- Date Received
- September 30, 2025
- Decision Date
- June 16, 2026
- Product Code
- SGL
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N