Trident Extremity Fixation System
FDA 510(k) clearance K171690 · decided 2018-05-08
Clearance details
- K-number
- K171690
- Device name
- Trident Extremity Fixation System
- Applicant
- Trident Orthopedics
- Decision
- Substantially Equivalent
- Date received
- 2017-06-07
- Decision date
- 2018-05-08
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Millersville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.