DeviceClearance

FIREBIRD SI Fusion System— 510(k) K200696

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K200696 for FIREBIRD SI Fusion System, Substantially Equivalent on 2020-04-02. Applicant: Orthofix, Inc.. Device class: 2.

Clearance details

Applicant
Orthofix, Inc.
Product code
Code OUR
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Lewisville, TX, US
Download summary PDFView on FDA.gov ↗

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More clearances from Orthofix, Inc.

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Adverse events under product code OUR

product code OUR
Death
3
Injury
347
Total
350

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K200696

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200696.

Data sourced from openFDA. This site is unofficial and independent of the FDA.