Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)— 510(k) K150064

Substantially Equivalent

Orthogem, Ltd.

FDA 510(k) clearance K150064 for Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15), Substantially Equivalent on 2015-09-04. Applicant: Orthogem, Ltd..

Clearance details

Applicant: Orthogem, Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2015-01-13
Decision date: 2015-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nottingham, GB

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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.