EXPEDIUM Spine System/Synapse System— 510(k) K142460

Name: FDA 510(k) clearance K142460
Creator: U.S. Food and Drug Administration
Published: 2014-10-01

Substantially Equivalent

Johnson and Johnson

FDA 510(k) clearance K142460 for EXPEDIUM Spine System/Synapse System, Substantially Equivalent on 2014-10-01. Applicant: Johnson and Johnson. Device class: 2.

Clearance details

Applicant: Johnson and Johnson
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-09-02
Decision date: 2014-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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K143278 — LnK Posterior Cervical Fixation System2015-07-29
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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

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K103488 — CONCORDE BULLET CAGE SYSTEM2011-03-02

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 →

Recalls naming K142460

K-number listed on FDA's recall record

Z-1674-2015 — EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467Class II·Terminated·DePuy Spine, Inc.·20150421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142460.

Data sourced from openFDA. This site is unofficial and independent of the FDA.