Deformity Analysis and Correction Software (DACS) and Instrumentation
FDA 510(k) clearance K180539 · decided 2018-08-13
Clearance details
- K-number
- K180539
- Device name
- Deformity Analysis and Correction Software (DACS) and Instrumentation
- Applicant
- Arrowhead Medical Device Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-02-28
- Decision date
- 2018-08-13
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- OSN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Collierville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.