5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)— 510(k) K022623

Name: FDA 510(k) clearance K022623
Creator: U.S. Food and Drug Administration
Published: 2002-08-27

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K022623 for 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM), Substantially Equivalent on 2002-08-27. 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: 2002-08-07
Decision date: 2002-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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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.