THE C-S DISTRACTION ROD ASSEMBLY— 510(k) K890187

Name: FDA 510(k) clearance K890187
Creator: U.S. Food and Drug Administration
Published: 1989-04-06

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K890187 for THE C-S DISTRACTION ROD ASSEMBLY, Substantially Equivalent on 1989-04-06. Applicant: Orthopedic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1989-01-18
Decision date: 1989-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Orthopedic Systems, Inc.

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K910736 — JACKSON MULTIPURPOSE OPERATING TABLE1991-05-21
K910031 — PARK CITY SHOULDER POSITIONER1991-01-24
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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.