PASS SPINAL SYSTEM— 510(k) K013191

Name: FDA 510(k) clearance K013191
Creator: U.S. Food and Drug Administration
Published: 2001-10-24

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K013191 for PASS SPINAL SYSTEM, Substantially Equivalent on 2001-10-24. Applicant: Encore Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2001-09-24
Decision date: 2001-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K020741 — UNICONDYLAR KNEE2002-06-04
K020236 — MODIFICATION TO PASS SPINAL SYSTEM2002-02-14
K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP2002-02-11

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.