ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY— 510(k) K070751

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K070751 for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY, Substantially Equivalent on 2007-10-15. Applicant: Isotis Orthobiologics, Inc..

Clearance details

Applicant: Isotis Orthobiologics, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2007-03-19
Decision date: 2007-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.