POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX— 510(k) K033707

Substantially Equivalent

Osteobiologics, Inc.

FDA 510(k) clearance K033707 for POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX, Substantially Equivalent on 2004-08-16. Applicant: Osteobiologics, Inc..

Clearance details

Applicant: Osteobiologics, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2003-11-26
Decision date: 2004-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, 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.