SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM— 510(k) K112025

Name: FDA 510(k) clearance K112025
Creator: U.S. Food and Drug Administration
Published: 2011-09-15

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K112025 for SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM, Substantially Equivalent on 2011-09-15. Applicant: Spinal USA. Device class: 2.

Clearance details

Applicant: Spinal USA
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2011-07-15
Decision date: 2011-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pear, MS, 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

More clearances from Spinal USA

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K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE2013-11-25
K130863 — FACET SCREW SYSTEM2013-08-09
K131343 — REFORM PEDICLE SCREW SYSTEM2013-07-24
K130279 — REFORM PEDICLE SCREW SYSTEM2013-06-20
K130445 — VAULT ALIF SYSTEM2013-04-25

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.