LOW PROFILE MID CROSS BRACING— 510(k) K931225

Name: FDA 510(k) clearance K931225
Creator: U.S. Food and Drug Administration
Published: 1994-05-02

Substantially Equivalent for Some Indications

Advanced Spine Fixation Systems, Inc.

FDA 510(k) clearance K931225 for LOW PROFILE MID CROSS BRACING, Substantially Equivalent for Some Indications on 1994-05-02. Applicant: Advanced Spine Fixation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Spine Fixation Systems, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1993-03-10
Decision date: 1994-05-02
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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K953779 — SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM1995-11-07
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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.