Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
FDA 510(k) clearance K221333 · decided 2022-12-29
Clearance details
- K-number
- K221333
- Device name
- Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
- Applicant
- Acumed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-05-09
- Decision date
- 2022-12-29
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hillsboro, OR, US
- Third-party review
- No
- Expedited review
- No
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