GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES— 510(k) K082615

Substantially Equivalent

Osteotech, Inc.

FDA 510(k) clearance K082615 for GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES, Substantially Equivalent on 2008-10-16. Applicant: Osteotech, Inc..

Clearance details

Applicant: Osteotech, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2008-09-09
Decision date: 2008-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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.