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