APEX SPINE SYSTEM— 510(k) K062513

Name: FDA 510(k) clearance K062513
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Spinecraft, Inc.

FDA 510(k) clearance K062513 for APEX SPINE SYSTEM, Substantially Equivalent on 2006-12-22. Applicant: Spinecraft, Inc.. Device class: 2.

Clearance details

Applicant: Spinecraft, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2006-08-28
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westchester, IL, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Spinecraft, Inc.

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K092825 — APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER2010-03-16
K062496 — OSTEOPORE TCP2006-10-19

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.