DeviceClearance

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional— 510(k) K221333

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K221333 for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional, Substantially Equivalent on 2022-12-29. Applicant: Acumed, LLC. Device class: 2.

Clearance details

Applicant
Acumed, LLC
Product code
Code HWC
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hillsboro, OR, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HWC

view all

More clearances from Acumed, LLC

view all

Adverse events under product code HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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 K221333

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 K221333.

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