IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
FDA 510(k) clearance K170312 · decided 2017-05-15
Clearance details
- K-number
- K170312
- Device name
- IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
- Applicant
- Medtronic Powered Surgical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2017-02-01
- Decision date
- 2017-05-15
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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Recalls involving this device
No recalls on record reference this clearance.