CD HORIZON SPINAL SYSTEM— 510(k) K961633

Name: FDA 510(k) clearance K961633
Creator: U.S. Food and Drug Administration
Published: 1996-12-05

Substantially Equivalent for Some Indications

Sofamor Danek USA,Inc.

FDA 510(k) clearance K961633 for CD HORIZON SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1996-12-05. Applicant: Sofamor Danek USA,Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1996-04-29
Decision date: 1996-12-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K991031 — COLORADO II SPINAL SYSTEM2000-05-10
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K992928 — CD HORIZON SPINAL SYSTEM1999-09-21
K991036 — DANEK PLATE AND SCREW SYSTEM1999-09-14
K991198 — DYNA-LOK PLUS SPINAL SYSTEM1999-08-27

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.