MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS— 510(k) K001105

Name: FDA 510(k) clearance K001105
Creator: U.S. Food and Drug Administration
Published: 2000-04-24

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K001105 for MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS, Substantially Equivalent on 2000-04-24. Applicant: Depuyacromed. Device class: 2.

Clearance details

Applicant: Depuyacromed
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2000-04-05
Decision date: 2000-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, 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 Depuyacromed

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K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM2004-04-02
K031635 — DEPUY ACROMED VBR SYSTEM2003-06-23
K030833 — DEPUY ACROMED VBR SYSTEM2003-04-10
K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS2003-02-26
K030249 — SURGICAL TITANIUM MESH SYSTEM2003-02-14

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.