KeYi Spinal Fixation System
FDA 510(k) clearance K190567 · decided 2019-05-08
Clearance details
- K-number
- K190567
- Device name
- KeYi Spinal Fixation System
- Applicant
- Beijing Keyi Medical Device Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-06
- Decision date
- 2019-05-08
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.