LimiFlex® Dynamic Sagittal Tether Instrument Set
FDA 510(k) clearance K253374 · decided 2026-06-16
Clearance details
- K-number
- K253374
- Device name
- LimiFlex® Dynamic Sagittal Tether Instrument Set
- Applicant
- Empirical Spine
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2026-06-16
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- SGL
- Device class
- 2
- Regulation number
- 888.4520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Morgan Hill, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.