PASSMED SPINAL SYSTEM— 510(k) K032094

Name: FDA 510(k) clearance K032094
Creator: U.S. Food and Drug Administration
Published: 2003-11-14

Substantially Equivalent

Medicrea

FDA 510(k) clearance K032094 for PASSMED SPINAL SYSTEM, Substantially Equivalent on 2003-11-14. Applicant: Medicrea. Device class: 2.

Clearance details

Applicant: Medicrea
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2003-07-07
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, 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 Medicrea

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K100484 — IMPIX MANTA CERVICAL INTERBODY DEVICE2010-03-16
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K050490 — OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER2005-04-11

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.