OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903— 510(k) K042305

Name: FDA 510(k) clearance K042305
Creator: U.S. Food and Drug Administration
Published: 2004-10-21

Substantially Equivalent

Ossacur AG

FDA 510(k) clearance K042305 for OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903, Substantially Equivalent on 2004-10-21. Applicant: Ossacur AG. Device class: 2.

Clearance details

Applicant: Ossacur AG
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2004-08-25
Decision date: 2004-10-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.