PASS OCT SPINAL SYSTEM— 510(k) K121979

Name: FDA 510(k) clearance K121979
Creator: U.S. Food and Drug Administration
Published: 2013-03-21

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K121979 for PASS OCT SPINAL SYSTEM, Substantially Equivalent on 2013-03-21. Applicant: Medicrea International. Device class: 2.

Clearance details

Applicant: Medicrea International
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2012-07-06
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, FR

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 Medicrea International

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K220810 — Infinity OCT System and PASS OCT Spinal System2022-04-19
K220724 — CD Horizon Spinal System and PASS LP Spinal System2022-04-08
K180091 — UNiD Spine Analyzer2018-02-08
K170172 — UNiD Spine Analyzer2017-05-24
K153169 — PASS OCT Patient Specific Rods2016-01-29

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.