TRUGRAFT BGS SYRINGE, MODEL 600-041— 510(k) K043172

Substantially Equivalent

Osteobiologics, Inc.

FDA 510(k) clearance K043172 for TRUGRAFT BGS SYRINGE, MODEL 600-041, Substantially Equivalent on 2005-01-07. Applicant: Osteobiologics, Inc..

Clearance details

Applicant: Osteobiologics, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2004-11-16
Decision date: 2005-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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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.