OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC— 510(k) K043421

Substantially Equivalent

Regeneration Technologies, Inc.

FDA 510(k) clearance K043421 for OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC, Substantially Equivalent on 2005-02-16. Applicant: Regeneration Technologies, Inc..

Clearance details

Applicant: Regeneration Technologies, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-12-13
Decision date: 2005-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, 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.