SPiN Thoracic Navigation System
FDA 510(k) clearance K170023 · decided 2017-05-15
Clearance details
- K-number
- K170023
- Device name
- SPiN Thoracic Navigation System
- Applicant
- Veran Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-03
- Decision date
- 2017-05-15
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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