Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
FDA 510(k) clearance K200043 · decided 2020-03-23
Clearance details
- K-number
- K200043
- Device name
- Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
- Applicant
- Field Orthopaedics Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-08
- Decision date
- 2020-03-23
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Spring Hill, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.