Solstice CCI— 510(k) K200896

Clearance details

Applicant

Life Spine, Inc.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2020-04-03

Decision date

2020-04-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Huntley, IL, US

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• K261430 — TruLift Expandable System2026-07-28
• K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments2026-06-02
• K260837 — VersaLift Expandable System2026-05-12
• K254274 — ARx® SAI Implant System2026-04-16
• K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System2026-01-23

Death

15

Injury

1,090

Malfunction

529

Total

1,634

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →