DeviceClearance

Cirq Arm System (2.0); Alignment System Spine— 510(k) K222966

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K222966 for Cirq Arm System (2.0); Alignment System Spine, Substantially Equivalent on 2022-10-27. Applicant: Brainlab AG. Device class: 2.

Clearance details

Device name as filed
Cirq Arm System (2.0);Alignment System Spine
Applicant
Brainlab AG
Product code
Code OLO
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Munich, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

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 K222966

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 K222966.

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