PIONEER SPINOUS PROCESS FUSION PLATE— 510(k) K101525

Name: FDA 510(k) clearance K101525
Creator: U.S. Food and Drug Administration
Published: 2010-10-22

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K101525 for PIONEER SPINOUS PROCESS FUSION PLATE, Substantially Equivalent on 2010-10-22. Applicant: Pioneer Surgical Technology. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2010-06-02
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Newbury, MA, 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 Pioneer Surgical Technology

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K110561 — FORTROSS BONE VOID FILLER2011-04-29
K101790 — QUANTUM SPINAL SYSTEM, QUANTUM MIS2011-03-07
K093692 — QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES2010-08-11
K093771 — QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM2010-08-10
K100708 — PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES2010-06-04

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.