Captiva Spine FuselOX Cervical IBF System— 510(k) K142586

Name: FDA 510(k) clearance K142586
Creator: U.S. Food and Drug Administration
Published: 2015-05-28

Substantially Equivalent

Captiva Spine

FDA 510(k) clearance K142586 for Captiva Spine FuselOX Cervical IBF System, Substantially Equivalent on 2015-05-28. Applicant: Captiva Spine. Device class: 2.

Clearance details

Applicant: Captiva Spine
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-09-15
Decision date: 2015-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jupiter, FL, US

Download summary PDF View on FDA.gov ↗

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K141332 — Captiva Spine SmartLOX Cervical Plate System2015-06-11
K131538 — CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM2013-08-08
K122956 — FUSELOX LUMBAR INTERBODY FUSION DEVICE2012-10-25

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.