OPACITY + BONE CEMENT— 510(k) K080873

Substantially Equivalent

Teknimed, S.A.

FDA 510(k) clearance K080873 for OPACITY + BONE CEMENT, Substantially Equivalent on 2008-08-28. Applicant: Teknimed, S.A..

Clearance details

Applicant: Teknimed, S.A.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2008-03-31
Decision date: 2008-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.