OSTEOPOWER SYSTEM AND ACCESSORIES— 510(k) K971692

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K971692 for OSTEOPOWER SYSTEM AND ACCESSORIES, Substantially Equivalent on 1997-06-27. Applicant: Osteomed Corp..

Clearance details

Applicant: Osteomed Corp.
Product code: Code KMW
Advisory panel: Dental
Date received: 1997-05-07
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMW

product code KMW

Injury: 175
Total: 175

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.