SOLSTICE OCT System— 510(k) K143249

Name: FDA 510(k) clearance K143249
Creator: U.S. Food and Drug Administration
Published: 2015-04-07

Substantially Equivalent

Life Spine, Inc.

FDA 510(k) clearance K143249 for SOLSTICE OCT System, Substantially Equivalent on 2015-04-07. Applicant: Life Spine, Inc.. Device class: 2.

Clearance details

Applicant: Life Spine, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-11-12
Decision date: 2015-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

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K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

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K254274 — ARx® SAI Implant System2026-04-16
K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System2026-01-23

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.