CD Horizon Spinal System and PASS LP Spinal System— 510(k) K220724

Name: FDA 510(k) clearance K220724
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K220724 for CD Horizon Spinal System and PASS LP Spinal System, Substantially Equivalent on 2022-04-08. Applicant: Medicrea International. Device class: 2.

Clearance details

Applicant: Medicrea International
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2022-03-14
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

view all

K262731 — Virata Spinal Fixation System2026-10-29
K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30

More clearances from Medicrea International

view all

K220810 — Infinity OCT System and PASS OCT Spinal System2022-04-19
K180091 — UNiD Spine Analyzer2018-02-08
K170172 — UNiD Spine Analyzer2017-05-24
K153169 — PASS OCT Patient Specific Rods2016-01-29
K150049 — PASS LP Spinal System2015-02-10

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.