OSTEOBOOST-BMA— 510(k) K062260

Substantially Equivalent

Orthos Limited

FDA 510(k) clearance K062260 for OSTEOBOOST-BMA, Substantially Equivalent on 2006-10-26. Applicant: Orthos Limited.

Clearance details

Applicant: Orthos Limited
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2006-08-04
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, North Somerset, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.