ORTHODOC PREOPERATIVE PLANNER MODEL 500— 510(k) K960685

Name: FDA 510(k) clearance K960685
Creator: U.S. Food and Drug Administration
Published: 1997-01-17

Substantially Equivalent

Integrated Surgical Systems, Inc.

FDA 510(k) clearance K960685 for ORTHODOC PREOPERATIVE PLANNER MODEL 500, Substantially Equivalent on 1997-01-17. Applicant: Integrated Surgical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Integrated Surgical Systems, Inc.
Product code: Code HWT
Device class: Class 1
Regulation: 21 CFR 888.4800
Advisory panel: Orthopedic
Date received: 1996-02-20
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.